scholarly journals Effectiveness and safety of Chinese herbal medicine xuanbi antong granules for the treatment of borderline coronary lesions: study protocol for a randomised, double-blinded, placebo-controlled, multicentre clinical trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e024968 ◽  
Author(s):  
Mingyan Huang ◽  
Guang Chen ◽  
Qingya Guan ◽  
Chao Liu ◽  
Qing Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Clinical Symptoms ◽  
Early Stage ◽  
Intervention Group ◽  
Blood Lipid ◽  
Controlled Clinical Trial ◽  
Cardiac Events ◽  
Coronary Syndrome ◽  
Double Blinded

IntroductionAs the early stage of coronary heart disease (CHD), borderline coronary lesion (BCL) is defined as a 30%–70% diameter stenosis. Previous studies have demonstrated that BCL may progress to acute coronary syndrome easily. However, routine medications available for the treatments of BCL have some limitations. Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years. Previous studies have shown that XAG has effectiveness in improving clinical symptoms and quality of life in patients with CHD. This study aims to evaluate the effectiveness and safety of XAG in patients with BCL.Methods and analysisThis is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 300 participants will be randomly assigned to the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with XAG and the placebo group will be treated with XAG placebo. All participants will receive a 6-month treatment and then be followed-up for another 6 months. The primary outcomes are the changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score) measured by dual source CT angiography. The secondary outcomes include blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events. All the data will be recorded in electronic case report forms and analysed by SPSS V.20.0.Ethics and disseminationThis study has been approved by Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2017–083-KY-01). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registration numberChiCTR-IOR-17013189; Pre-results.

scholarly journals Effect of hand reflexology on anxiety and physiological variables among patients hospitalized in the cardiac care unit: A randomized placebo controlled clinical trial

2017 ◽  
Vol 8 (4) ◽  
pp. 35 ◽  
Author(s):  
Zohre Rahmani ◽  
Nahid Rejeh ◽  
Majideh Heravi-Karimooi ◽  
Seyed Davood Tadrisi ◽  
Mojtaba Vaismoradi
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Intervention Group ◽  
Anxiety Level ◽  
Cardiac Care ◽  
Controlled Clinical Trial ◽  
Female Patients ◽  
Coronary Syndrome ◽  
Physiological Variables ◽  
Cardiac Care Unit

Background and objective: Admission to the cardiac care unit may cause physiological and psychological problems in patients. This study aimed to investigate the effect of hand reflexology on anxiety and physiological variables among female patients with acute coronary syndrome hospitalized in the cardiac care unit.Methods: This randomized placebo controlled clinical trial was conducted on 90 female patients hospitalized in the cardiac care unit in an urban area of Iran. The patients were chosen using a convenient sampling method and then were randomly assigned into intervention (n = 45) and placebo (n = 45) groups. While the intervention group received hand reflexology for 20 minutes, the placebo group received a simple touch of hand without the stimulation of reflexology points.  Demographic data was collected at the beginning of the study using face-to-face interviews with the patients. The anxiety level was assessed using the Spielberger’s State-Trait Anxiety Inventory (STAI) immediately after the intervention and 30 min after the intervention. Also, physiological variables including respiratory rate, heart rate, blood pressure and oxygen saturation were measured before, immediately after the intervention and 30 minutes after the intervention. Descriptive and inferential statistics were used for data analysis.Results: There was no statistically significant difference between the intervention and placebo groups before the intervention (p > .05). The anxiety level in the intervention group was significantly lower than that of the placebo group immediately after the intervention and 30 minutes after the intervention (p < .05, η = 0.090). However, no statistically significant differences in physiological variables between the groups were observed (p > .05).Conclusions: Hand reflexology influenced the level of anxiety. Therefore, nurses can use hand reflexology as a method for reducing patients’ anxiety along with other nursing interventions.

scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. e1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Common Cold ◽  
Primary Outcome Measure ◽  
Drug Group ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Preventive Efficacy ◽  
Double Blinded ◽  
Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]  

scholarly journals Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001455 ◽  
Author(s):  
Maria Isabel Lopes ◽  
Leticia P Bonjorno ◽  
Marcela C Giannini ◽  
Natalia B Amaral ◽  
Pamella Indira Menezes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Standard Treatment ◽  
Supplemental Oxygen ◽  
Controlled Clinical Trial ◽  
Beneficial Effects ◽  
Primary Endpoints ◽  
Registration Number ◽  
Double Blinded ◽  
Supplemental Oxygen Therapy

ObjectiveTo evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes.DesignWe present the results of a randomised, double-blinded, placebo-controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 75 patients allocated 1:1 from 11 April to 30 August 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The primary endpoints were the need for supplemental oxygen, time of hospitalisation, need for admission and length of stay in intensive care unit and death rate.ResultsSeventy-two patients (36 for placebo and 36 for colchicine) completed the study. Median (and IQR) time of need for supplemental oxygen was 4.0 (2.0–6.0) days for the colchicine group and 6.5 (4.0–9.0) days for the placebo group (p<0.001). Median (IQR) time of hospitalisation was 7.0 (5.0–9.0) days for the colchicine group and 9.0 (7.0–12.0) days for the placebo group (p=0.003). At day 2, 67% versus 86% of patients maintained the need for supplemental oxygen, while at day 7, the values were 9% versus 42%, in the colchicine and the placebo groups, respectively (log rank; p=0.001). Two patients died, both in placebo group. Diarrhoea was more frequent in the colchicine group (p=0.26).ConclusionColchicine reduced the length of both, supplemental oxygen therapy and hospitalisation. The drug was safe and well tolerated. Once death was an uncommon event, it is not possible to ensure that colchicine reduced mortality of COVID-19.Trial registration numberRBR-8jyhxh.

The Preventive Effects of Boron-Based Gel on Radiation Dermatitis in Patients Being Treated for Breast Cancer: A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2022 ◽  
pp. 1-8
Author(s):  
Fikrettin Sahin ◽  
Mohammad Bagher Pirouzpanah ◽  
Hossein Bijanpour ◽  
Mohammad Mohammadzadeh ◽  
Reza Eghdam Zamiri ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Placebo Group ◽  
Intervention Group ◽  
Phase Iii ◽  
Radiation Dermatitis ◽  
Placebo Control ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Moist Desquamation

<b><i>Introduction:</i></b> Radiation dermatitis (RD) is a side effect of radiation therapy (RT) which is experienced by over 90% of patients being treated for breast cancer. The current clinical trial was conducted to measure the preventative effects of a boron-based gel on several different clinical outcomes (dermatitis, erythema, dry desquamation, and moist desquamation) after 25 radiotherapy sessions. <b><i>Methods:</i></b> This research used a double-blind parallel-group design with a placebo control (<i>n</i> = 76) and randomized group (<i>n</i> = 181), with all participants being between 18 and 75 years old. Fifteen minutes before each radiotherapy, participants in the intervention group were given a gel containing 3% sodium pentaborate pentahydrate, while those in the placebo group received a gel with no chemical substance. Dermatitis, erythema, dry desquamation, and moist desquamation were compared between the 2 groups. <b><i>Results:</i></b> At baseline, there were no significant differences between the groups (<i>p</i> &#x3e; 0.05), except for body mass index. After 14 days of treatment, dermatitis (98.7% vs. 9.9%; <i>p</i> &#x3c; 0.001), erythema (96.1% vs. 12.2%; <i>p</i> &#x3c; 0.001), dry desquamation (50% vs. 3.9%; <i>p</i> &#x3c; 0.001), and moist desquamation (18.4% vs. 0.6%; <i>p</i> &#x3c; 0.001) were much more common in the placebo group than the intervention group. To prevent dermatitis, erythema, dry desquamation, and moist desquamation in 1 patient, on average, 1.1 (95% confidence interval [CI]: 1.1–1.2), 1.2 (95% CI: 1.1–1.3), 2.2 (95% CI: 1.7–2.9), and 5.6 (95% CI: 3.8–11.0) patients need to be treated, respectively. <b><i>Conclusion:</i></b> The boron-based gel has a significant preventive effect on several categories of RD which might be used by clinicians in breast cancer.

The Role of Vitamin D Supplementation in the Treatment of Primary Hypertension: A Double-Blinded Randomized Placebo-Controlled Clinical Trial

2020 ◽  
Vol 22 (7) ◽  
Author(s):  
Samira Faraji ◽  
Rasoul Zarrin ◽  
Asma Zamanian ◽  
Reza Hajizadeh ◽  
Parvin Ayremlou ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Vitamin D ◽  
Lipid Profile ◽  
Vitamin D Deficiency ◽  
Intervention Group ◽  
Vitamin D Supplementation ◽  
Controlled Clinical Trial ◽  
Hypertensive Patients ◽  
Double Blinded

Background: Hypertension is one of the most serious global concerns since it has affected over 1.2 billion people. Objectives: The present study aimed to determine the effect of vitamin D supplementation on blood pressure, fasting blood sugar, and lipid profile in hypertensive patients with vitamin D deficiency. Methods: In this double-blinded randomized placebo-controlled clinical trial study, 116 hypertensive patients (intervention and placebo groups, 58 each) with vitamin D deficiency (< 30 ng/mL with ECL) for 14 weeks, started from the beginning of autumn 2019 in Seyed-al-Shohada Educational Hospital in Urmia City. Fifty-five patients (49%) were male with the mean vitamin D 15.89 ± 5.09 ng/mL and 57 females with 17.29 ± 6.31 ng/mL. In a stratified blocked randomization scheme, the patients were randomly allocated into similar sized intervention and control groups based on body mass index (BMI), then the randomization with four block size was performed in each of strata by random allocation software. The intervention group received six doses of 50,000 IU vitamin D supplements for 6 weeks, then two supplements for two following months (one capsule per month). Blood pressure (24/h blood pressure measured by an ambulatory blood pressure monitoring device), vitamin D, FBS, and lipid profile (HDL, LDL, CL, and TG) were all measured at baseline and end of the study. Physical activity (measured by short IPAQ questionnaire), sun exposure using a questionnaire, dietary intake of vitamin D using three 24-hour recalls during the intervention, and anthropometric indices were measured at baseline, middle, and end of the study. Fifty-six patients in each group completed the study. The study was approved by the Ethics Committee of the Urmia University of Medical Sciences (ethics code: IR.UMSU.REC.1398.192). Results: The office blood pressure, 24-h systolic blood pressure (SBP) and diastolic blood pressure (DBP), nighttime SBP and DBP were significantly reduced in the intervention group compared to the control group, whereas the reduction of daytime SBP and DBP was not statistically significant. Vitamin D supplementation significantly decreased serum triglyceride, cholesterol, and LDL levels. Conclusions: Vitamin D supplementation had positive effects on blood pressure, triglyceride, cholesterol, and LDL levels in patients with low serum vitamin D.

scholarly journals Efficacy of transdermal delivery of liposomal micronutrients through body oil massage on neurodevelopmental and micronutrient deficiency status in infants: results of a randomized placebo-controlled clinical trial

BMC Nutrition ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Aditi Apte ◽  
Mudra Kapoor ◽  
Sadanand Naik ◽  
Himangi Lubree ◽  
Pooja Khamkar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Placebo Group ◽  
Motor Development ◽  
Transferrin Saturation ◽  
Intervention Group ◽  
Micronutrient Deficiency ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Moderate Anemia

Abstract Background Micronutrient deficiency is a known cause of adverse neurodevelopment and growth. Poor adherence to oral regimes of micronutrient supplements is a known challenge during the implementation of supplementation programs. The present study evaluates the benefits of liposomal encapsulated micronutrient fortified body oils (LMF oil) that can be used for infant body massage in terms of neurodevelopment and prevention of deficiency. Study design Double-blind randomized clinical trial. Methods A total of 444 healthy infants aged 4-7 weeks were randomized to receive either LMF oil (containing iron, vitamin D, folate, and vitamin B12) or placebo oil for gentle body massage till 12 months of age. Blood samples were collected at 6 and 12 months for transferrin saturation (TSAT), hemoglobin, and 25-hydroxy vitamin (25-OH-D) levels. Mental and motor development was assessed at 12 months using developmental assessment for Indian Infants (DASII). Results A total of 391 infants completed the study. There was no significant improvement in the hemoglobin in the intervention group at 12 months of age as compared to the placebo group [− 0.50 vs.-0.54 g%]. There was a marginally significant improvement in 25-OH-D at 12 months in the LMF oil group [+ 1.46vs.-0.18 ng/ml, p = 0.049]. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age [adjusted mean change + 0.11vs.-0.51 g%, p = 0.043]. The mental or motor developmental quotients in the intervention group were not significantly different from those in the placebo group. Conclusion Use of LMF oil for prevention of nutritional deficiency did not offer significant protection against nutritional anemia but prevented vitamin D deficiency to some extent with improvement in 25-OH-D at 12 months. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age. The intervention did not result in significant improvement in mental or motor development. Further evaluation with increased doses needs to be undertaken. Trial registration CTRI no: CTRI/2017/11/010710; dated 30/11/2017.

scholarly journals Beneficial effects of colchicine for moderate to severe COVID-19: an interim analysis of a randomized, double-blinded, placebo controlled clinical trial

2020 ◽  
Author(s):  
Maria Isabel F Lopes ◽  
Leticia P Bonjorno ◽  
Marcela C Giannini ◽  
Natalia B Amaral ◽  
Maira N Benatti ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Adverse Events ◽  
Interim Analysis ◽  
Supplemental Oxygen ◽  
Serum Lactate Dehydrogenase ◽  
Controlled Clinical Trial ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Double Blinded

Introduction. Neutrophilia and high levels of proinflammatory cytokines and other mediators of inflammation are common finds in patients with severe acute respiratory syndrome due to COVID-19, a dramatic condition for which there is no specific treatment, but supportive care and attempts to control the systemic inflammation. By its action on leukocytes, we propose colchicine as an intervention worthy of being tested. Objective. To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes. Methods. We present the interim analysis of a single-center randomized, double-blinded, placebo controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 38 patients allocated 1:1 from April 11 to July 06, 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The first dose was 1.0 mg whether body weight was ≥ 80 kg. Endpoints. The primary endpoints were the need for supplemental oxygen; time of hospitalization; need for admission and length of stay in intensive care unit; and death rate and causes of mortality. As secondary endpoints, we assessed: serum C-reactive protein, serum Lactate dehydrogenase and relation neutrophil to lymphocyte of peripheral blood samples from day zero to day 7; the number, type, and severity of adverse events; frequency of interruption of the study protocol due to adverse events; and frequency of QT interval above 450 ms. Results. Thirty-five patients (18 for Placebo and 17 for Colchicine) completed the study. Both groups were comparable in terms of demographic, clinical and laboratory data at baseline. Median (and interquartile range) time of need for supplemental oxygen was 3.0 (1.5-6.5) days for the Colchicine group and 7.0 (3.0-8.5) days for Placebo group (p = 0.02). Median (IQR) time of hospitalization was 6.0 (4.0-8.5) days for the Colchicine group and 8.5 (5.5-11.0) days for Placebo group (p = 0.03). At day 2, 53% vs 83% of patients maintained the need for supplemental oxygen, while at day 7 the values were 6% vs 39%, in the Colchicine and Placebo groups, respectively (log rank; p = 0.01). Hospitalization was maintained for 53% vs 78% of patients at day 5 and 6% vs 17% at day 10, for the Colchicine and Placebo groups, respectively (log rank; p = 0.01). One patient per group needed admission to ICU. No recruited patient died. At day 4, patients of Colchicine group presented significant reduction of serum C-reactive protein compared to baseline (p < 0.001). The majority of adverse events were mild and did not lead to patient withdrawal. Diarrhea was more frequent in the Colchicine group (p = 0.17). Cardiac adverse events were absent. Discussion. The use of colchicine reduced the length of both, supplemental oxygen therapy and hospitalization. Shortly less than half of the patients of the Colchicine group stopped receiving supplemental oxygen until day 2. Clinical improvement was in parallel with a reduction on serum levels of C-reactive protein. The drug was safe and well tolerated. Colchicine may be considered a beneficial and not expensive option for COVID-19 treatment. Clinical trials with larger numbers of patients should be conducted to further evaluate the efficacy and safety of colchicine as an adjunctive therapy for hospitalized patients with moderate to severe COVID-19.

Protective effect of N-acetylcysteine on oxaliplatin-induced neurotoxicity in patients with colorectal and gastric cancers: A randomized, double blind, placebo-controlled, clinical trial

2020 ◽  
Vol 26 (7) ◽  
pp. 1575-1582
Author(s):  
Nazanin Bondad ◽  
Reza Boostani ◽  
Alireza Barri ◽  
Sepideh Elyasi ◽  
Abolghasem Allahyari
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Chemotherapeutic Agents ◽  
Colorectal Cancers ◽  
Controlled Clinical Trial ◽  
Preventive Effect ◽  
Double Blind ◽  
Grading Scale ◽  
Double Blinded ◽  
Assessment Result

Purpose Neuropathy is one of the most prevalent and dose-limiting side effects of platinum chemotherapeutic agents. N-acetylcysteine is an antioxidant thiol which is able to increase whole blood concentration of glutathione, which may be protective against chemotherapy-induced neuropathy. The aim of this study was to evaluate the effect of N-acetylcysteine on neurotoxicity induced by oxaliplatin in patients with gastric or colorectal cancers. Methods During this randomized, double‐blinded, placebo‐controlled clinical trial, the preventive effect of N-acetylcysteine effervescent tablets was assessed in comparison with placebo, on neuropathy occurrence. Thirty-two patients with colorectal or gastric cancer randomly received N-acetylcysteine (two 600 mg tablets) or placebo tablets 1 h before receiving oxaliplatin in dose in XELOX (oxaliplatin and capecitabine regimen) for eight courses of chemotherapy. Neuropathy severity was assessed after eight courses of chemotherapy based on National Cancer Institute Common Terminology for Adverse Events (NCI‐CTCAE) criteria neuropathy grading scale and also sensory and motor electrophysiological assessment was performed by a neurologist. Results The NCI-CTCAE scale grade of patients in intervention group was significantly lower than placebo group after eight course of oxaliplatin ( P = 0.01); however, the sensory electrophysiological assessment result was not significantly different ( P = 0.501). No patient in both group had motor electrophysiological changes. Conclusion The results of this study showed that N-acetylcysteine could reduce the incidence of the neuropathy induced by oxaliplatin and delay its occurrence in patients with gastric or colorectal cancers.

scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. 1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Common Cold ◽  
Primary Outcome Measure ◽  
Drug Group ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Preventive Efficacy ◽  
Double Blinded ◽  
Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]

scholarly journals Title: Efficacy of transdermal delivery of liposomal micronutrients through body oil massage on neurodevelopmental and micronutrient deficiency status in infants: Results of a randomized placebo controlled clinical trial 

2021 ◽  
Author(s):  
Aditi Apte ◽  
Mudra Kapoor ◽  
Sadanand Naik ◽  
Himangi Lubree ◽  
Pooja Khamkar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Placebo Group ◽  
Motor Development ◽  
Transferrin Saturation ◽  
Intervention Group ◽  
Micronutrient Deficiency ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Moderate Anemia

Abstract Background: Micronutrient deficiency is a known cause of adverse neurodevelopment and growth. Poor adherence to oral regimes of micronutrient supplements is a known challenge during the implementation of supplementation programs. The present study evaluates the benefits of liposomal encapsulated micronutrient fortified body oils (LMF oil) that can be used for infant body massage in terms of neurodevelopment and prevention of deficiency. Study design: Double-blind randomized clinical trial Methods: 444 healthy infants aged 4-7weeks were randomized to receive either LMF oil (containing iron, vitamin D, folate, and vitamin B12) or placebo oil for gentle body massage till 12months of age. Blood samples were collected at 6 and 12 months for transferrin saturation (TSAT), hemoglobin, and 25-hydroxy vitamin (25-OH-D) levels. Mental and motor development was assessed at 12 months using developmental assessment for Indian Infants (DASII). Results: A total of 391 infants completed the study. There was no significant improvement in the hemoglobin in the intervention group at 12 months of age as compared to the placebo group [-0.50 vs.-0.54 gm%]. There was a marginally significant improvement in 25-OH-D at 12 months in the LMF oil group [+1.46vs.-0.18ng/ml, p=0.049]. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age [adjusted mean change +0.11vs.-0.51gm%, p=0.043]. The mental or motor developmental quotients in the intervention group were not significantly different from those in the placebo group. Conclusion: Use of LMF oil for prevention of nutritional deficiency did not offer significant protection against nutritional anemia but prevented vitamin D deficiency to some extent with improvement in 25-OH-D at 12 months. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age. The intervention did not result in significant improvement in mental or motor development. Further evaluation with increased doses needs to be undertaken.Trial registration: CTRI no: CTRI/2017/11/010710; dated 30/11/2017 [http://ctri.nic.in/Clinicaltrials/advancesearchmain.php ]

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