The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT

Abstract Background Since a few years, the laparoscopic sleeve gastrectomy (SG) has become the most performed bariatric operation worldwide. However, as with all bariatric procedures, SG also leads to vitamin and mineral deficiencies post-operatively and standard multivitamin supplements are probably not sufficient. Objective The present study evaluates the effectiveness of a specialized multivitamin supplement for SG patients (WLS Optimum 1.0, FitForMe, Rotterdam, the Netherlands), compared to a standard multivitamin supplement (sMVS). Design A double-blind randomized controlled trial was performed. For 12 months, patients in the intervention group received WLS Optimum, containing elevated doses of multiple vitamins and minerals. Patients in the control group were provided with sMVS, containing 100% of the recommended dietary allowance. Results In total, 139 patients were available for analysis (WLS Optimum, n = 69; sMVS, n = 70). Intention-to-treat analyses revealed more folic acid deficiencies and higher serum vitamin B1 levels in the WLS Optimum group. Per protocol analyses showed that in patients using WLS Optimum, serum folic acid and vitamin B1 levels were higher, serum PTH levels were lower, and only one patient (2.6%) was anemic compared to 11 patients (17.5%) using a sMVS (p < 0.05 for all). No differences were found in prevalence of deficiencies for iron, vitamin B12, vitamin D, and other vitamins and minerals. Conclusions This optimized multivitamin supplement only affected serum levels of folic acid, PTH and vitamin B1, and anemia rates compared to a sMVS. There is a clear need to further optimize multivitamin supplementation for SG patients. Besides, non-compliance with multivitamin supplements remains an important issue that should be dealt with. Clinical Trial Registry The study protocol was registered at the clinical trials registry of the National Institutes of Health (ClinicalTrials.gov; identifier NCT01609387).

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Optimizing Multivitamin Supplementation for Sleeve Gastrectomy Patients

Obesity Surgery ◽

10.1007/s11695-021-05282-4 ◽

2021 ◽

Author(s):

Laura Heusschen ◽

Agnes A. M. Berendsen ◽

Mellody I. Cooiman ◽

Laura N. Deden ◽

Eric J. Hazebroek ◽

...

Keyword(s):

Sleeve Gastrectomy ◽

Vitamin B12 ◽

Vitamin B6 ◽

Controlled Trial ◽

Serum Vitamin ◽

Serum Levels ◽

Multivitamin Supplementation ◽

Serum Vitamin D ◽

Multivitamin Supplement ◽

Vitamin D Levels

Abstract Purpose Micronutrient deficiencies are frequently reported after sleeve gastrectomy (SG), and therefore lifelong daily multivitamin supplementation is highly recommended. Based on literature and the results of a previous randomized controlled trial, a specialized multivitamin supplement for SG patients was further optimized (WLS Optimum 2.0, FitForMe). The present study reports on its short-term effectiveness. Materials and Methods An open-label study was performed in which 76 patients were included to receive WLS Optimum 2.0 for 12 months (Opt 2.0 group). This group was compared with a group of 75 patients that had received WLS Optimum 1.0 for 12 months during a previous study (Opt 1.0 group). Results Intention-to-treat analysis (Opt 1.0, n = 69; Opt 2.0, n = 75) showed higher serum levels of vitamin B12, vitamin B6, and zinc, and a lower prevalence of deficiencies for vitamin B12 and phosphate in the Opt 2.0 group. MCV and serum folic acid levels were higher in the Opt 1.0 group. Over the 12-month study period, mean increase in serum levels of phosphate, vitamin B6, and zinc was higher in the Opt 2.0 group, and MCV and serum vitamin D levels increased more in the Opt 1.0 group. Conclusion The present study showed that the use of a specialized multivitamin supplement for SG patients is effective at preventing deficiencies for most vitamins and minerals, specifically in compliant patients. However, a strict follow-up regime remains necessary to monitor nutritional status and to improve patient compliance.

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Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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Effects of Periconceptional Multivitamin Supplementation on Folate and Homocysteine Levels Depending on Genetic Variants of Methyltetrahydrofolate Reductase in Infertile Japanese Women

Nutrients ◽

10.3390/nu13041381 ◽

2021 ◽

Vol 13 (4) ◽

pp. 1381

Author(s):

Keiji Kuroda ◽

Takashi Horikawa ◽

Yoko Gekka ◽

Azusa Moriyama ◽

Kazuki Nakao ◽

...

Keyword(s):

Folic Acid ◽

Methylenetetrahydrofolate Reductase ◽

Homocysteine Level ◽

Folic Acid Supplementation ◽

Serum Folate ◽

Folate Level ◽

Multivitamin Supplementation ◽

Mthfr Polymorphisms ◽

Mthfr Genotype ◽

Multivitamin Supplements

Methylenetetrahydrofolate reductase (MTHFR) has various polymorphisms, and the effects of periconceptional folic acid supplementation for decreasing neural tube defects (NTDs) risk differ depending on the genotypes. This study analyzed the effectiveness of multivitamin supplementation on folate insufficiency and hyperhomocysteinemia, depending on MTHFR polymorphisms. Of 205 women, 72 (35.1%), 100 (48.8%) and 33 (16.1%) had MTHFR CC, CT and TT, respectively. Serum folate and homocysteine levels in women with homozygous mutant TT were significantly lower and higher, respectively, than those in women with CC and CT. In 54 women (26.3% of all women) with a risk of NTDs, multivitamin supplementation containing folic acid and vitamin D for one month increased folate level (5.8 ± 0.9 to 19.2 ± 4.0 ng/mL, p < 0.0001) and decreased the homocysteine level (8.2 ± 3.1 to 5.8 ± 0.8 nmol/mL, p < 0.0001) to minimize the risk of NTDs in all women, regardless of MTHFR genotype. Regardless of MTHFR genotype, multivitamin supplements could control folate and homocysteine levels. Tests for folate and homocysteine levels and optimal multivitamin supplementation in women with risk of NTDs one month or more before pregnancy should be recommended to women who are planning a pregnancy.

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Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽

10.1136/bmjopen-2020-041958 ◽

2020 ◽

Vol 10 (10) ◽

pp. e041958

Author(s):

Nirmani Yasara ◽

Nethmi Wickramarathne ◽

Chamila Mettananda ◽

Aresha Manamperi ◽

Anuja Premawardhena ◽

...

Keyword(s):

Clinical Trial ◽

Sri Lanka ◽

Intervention Group ◽

Primary Outcome Measure ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Scientific Publications ◽

Double Blind ◽

Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

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Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

European Respiratory Journal ◽

10.1183/13993003.00752-2021 ◽

2021 ◽

pp. 2100752

Author(s):

Pradeesh Sivapalan ◽

Charlotte Suppli Ulrik ◽

Therese Sophie Lapperre ◽

Rasmus Dahlin Bojesen ◽

Josefin Eklöf ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Safety Outcome ◽

Hospitalised Patients ◽

Double Blinded ◽

Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

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The efficacy of multidisciplinary rehabilitation in stable multiple sclerosis patients

Multiple Sclerosis Journal ◽

10.1191/135248506ms1250oa ◽

2006 ◽

Vol 12 (2) ◽

pp. 235-242 ◽

Cited By ~ 38

Author(s):

L K Storr ◽

P S Sørensen ◽

M Ravnborg

Keyword(s):

Multiple Sclerosis ◽

Outcome Measures ◽

Bodily Pain ◽

Intervention Group ◽

Inpatient Rehabilitation ◽

Control Group ◽

Double Blind ◽

Multidisciplinary Rehabilitation ◽

Upper Limb Function ◽

Multiple Sclerosis Patients

Objective To evaluate the short-term efficacy of multidisciplinary, inpatient rehabilitation of multiple sclerosis (MS) patients. Methods A double-blind, randomized, parallel group design was used. The intervention group were offered comprehensive, multidisciplinary inpatient rehabilitation at the Haslev MS Hospital for an average of 35.5 days, while the control group received no treatment related to the study. All patients were examined in their homes twice with a 10-week interval. The rehabilitation of the intervention group started 2-3 weeks after the first examination and ended 2-3 weeks before the second examination. Impairment was assessed by the Multiple Sclerosis Impairment Scale and the Expanded Disability Status Scale. Disability was assessed by means of Guy’s Neurological Disability Scale. Two specific scales were used to assess upper limb function and ambulation: The Nine-Hole Peg Test and timed 10-metre walking. Patients’ own perception of bodily pain, bladder symptoms, spasticity, fatigue, impaired walking and transfers were recorded using visual analogue scales. Finally, quality of life was assessed using the Life Appreciation and Satisfaction Questionnaire and the Functional Assessment in Multiple Sclerosis. Patients Two hundred and thirty-three patients were screened and of those 38 were included for treatment and 52 as controls. Results We found no statistically significant differences between the two groups in any of the outcome measures. Conclusion Although the study was underpowered, the negative outcome exposes the difficulties in quantitative analyses of the efficacy of multidisciplinary rehabilitation, which is liable to confounding factors such as variation in the indication for treatment, in the placebo effect, and in the reliability and responsiveness of the outcome measures.

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Effect of Oral Ingestion of Low-Molecular Collagen Peptides Derived from Skate (Raja Kenojei) Skin on Body Fat in Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Marine Drugs ◽

10.3390/md17030157 ◽

2019 ◽

Vol 17 (3) ◽

pp. 157 ◽

Cited By ~ 6

Author(s):

Young Tak ◽

Yun Kim ◽

Jeong Lee ◽

Yu-Hyun Yi ◽

Young Cho ◽

...

Keyword(s):

Body Fat ◽

Animal Studies ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Collagen Peptides ◽

Collagen Peptide ◽

Skin Collagen ◽

Overweight Adults

Recent animal studies found the potential of a collagen peptide derived from skate skin to have anti-obesity effects through the suppression of fat accumulation and regulation of lipid metabolism. However, no studies have yet been performed in humans. Here, this very first human randomized, placebo-controlled, and double-blinded study was designed to investigate the efficacy and tolerability of skate skin collagen peptides (SCP) for the reduction of body fat in overweight adults. Ninety healthy volunteers (17 men) aged 41.2 ± 10.4 years with a mean body mass index of 25.6 ± 1.9 kg/m2 were assigned to the intervention group (IG), which received 2000 mg of SCP per day or to the control group (CG) given the placebo for 12 weeks and 81 (90%) participants completed the study. Changes in body fat were evaluated using dual energy X-ray absorptiometry as a primary efficacy endpoint. After 12 weeks of the trial, the percentage of body fat and body fat mass (kg) in IG were found to be significantly better than those of subjects in CG (−1.2% vs. 2.7%, p = 0.024 and −1.2 kg vs. 0.3 kg, p = 0.025). Application of SCP was well tolerated and no notable adverse effect was reported from both groups. These results suggest the beneficial potential of SCP in the reduction of body fat in overweight adults.

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Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: A double-blind, randomized, placebo-controlled trial

10.21203/rs.3.rs-18733/v2 ◽

2020 ◽

Author(s):

Hadi Bazyar ◽

Ahmad Zare Javid ◽

Hossein Bavi Behbahani ◽

Fardin Moradi ◽

Bahman Moradi Poode ◽

...

Keyword(s):

Diabetes Mellitus ◽

Disease Risk ◽

Controlled Trial ◽

Cardiovascular Disease Risk ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Anthropometric Indices ◽

Double Blind ◽

Conicity Index

Abstract Background: Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM).Materials and Methods: In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for eight weeks. Mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHR) were evaluated in all the patients pre- and post-intervention.Results: Melatonin supplementation for eight weeks significantly decreased the mean levels of MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHR post-intervention (p<0.05). Also, the median changes of MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p<0.05). A significant increase (p<0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p<0.001).Conclusions: Consumption of melatonin supplement may be effective in controlling arterial pressure and anthropometric indices (as predictors of obesity) in T2DM patients.Trial registration: This trial was registered in the Iranian Registry of Clinical Trials website at 2019/5/17. (IRCT20190303042905N1).

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EFEK SUPLEMENTASI MULTIVITAMIN MINERAL TERHADAP KADAR HEMOGLOBIN DAN HEMATOKRIT MAHASISWI TPB IPB

Jurnal Gizi dan Pangan ◽

10.25182/jgp.2013.8.1.47-54 ◽

2013 ◽

Vol 8 (1) ◽

pp. 47

Author(s):

Angga Hardiansyah ◽

Rimbawan Rimbawan ◽

Ikeu Ekayanti

Keyword(s):

Intervention Group ◽

Statistical Test ◽

Female Students ◽

Control Group ◽

Blood Biomarkers ◽

Control Groups ◽

Double Blind ◽

Mineral Supplementation ◽

Quasi Experimental ◽

And Control

The objective of this study was to analyze effect of multivitamin mineral supplementation to hemoglobin and hematocrit concentration of Bogor Agricultural University First Common Year female students. Design of this study was the quasi experimental, double blind, with number of subjects were 28 female students devided into two group. The intervention group consisted of 15 subjects, received supplement syrup 15 ml per day for eight weeks.The control group consisted of 13 subjects received placebo syrup. Data collected by interviewing subjects used questionnaire, physical examination, and blood biomarkers. The results of statistical test (paired sample t-test) showed that there were no significant increase in hemoglobin and hematocrit concentration respectively in both intervention and control groups (p>0.05). However, on a subset of subjects anemia, the hemoglobin and hematocrit in the intervention group tended to increase larger than the control group.<br /><br />

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The Effect of Vitamin B6 on Reducing the Number and the Size of Breast Cysts and the Amount of Recurrence after Aspiration in Women

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v31i630348 ◽

2019 ◽

pp. 1-7

Author(s):

Setareh Soltany ◽

Hamid Reza Hemmati ◽

Jafar Alavy Toussy ◽

Parisa Alavi Toosi

Keyword(s):

Vitamin B6 ◽

Intervention Group ◽

Control Group ◽

Control Groups ◽

Double Blind ◽

Breast Cyst ◽

The Difference ◽

Palpable Breast ◽

Breast Lumps ◽

And Control

Introduction: Palpable breast lumps are one of the most prevalent breast problems in women who visit a doctor. Most of these lumps are benign, and many of these benign lumps, have cystic nature. One of the suggested treatments for breast cyst is vitamin B6 intake. So, this study aimed to determine the effect of vitamin B6 on reducing the number and the size of breast cysts and reducing the amount of recurrence after aspiration. Materials and Methods: This study is a double-blind randomized clinical trial. Patients simply divided into two groups randomly, intervention group (receiving 150 mg vitamin B6 twice a day for two months) and control group (placebo). After data collection, the database produced, and information came in by SPSS-22 software. Descriptive results extracted in the form of tables and graphs. In all cases was used α=0.05. Results: At the end of the study, 65 patients (34 people in the intervention group, and 31 people in the control group) studied. At the end of the survey in the non-palpable cysts, was observed a significant decrease in the number and the size of breast cysts in each group receiving vitamin B6 or placebo. Still, the difference was not significant in comparing the two groups. 19 patients (2.29%) had palpable cysts that aspiration performed in all cases. After the study period, no recurrence of cysts observed in any of the intervention and control groups. Conclusion: The study showed that vitamin B6 had no effect on reducing the size and the number of non-palpable breast cysts and prevent recurrence of palpable cysts after aspiration.

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