Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)–DYAD Randomized Controlled Trial

ABSTRACT Background Adequate knowledge about the safety of consumption of small-quantity lipid-based nutrient supplements (SQ-LNSs) is needed. Objective We aimed to test the hypothesis that SQ-LNS consumption is noninferior to control with respect to child morbidity. Methods Women (n = 1320) ≤20 wk pregnant were assigned to iron and folic acid until delivery with no supplementation for offspring; or multiple micronutrient supplements until 6 mo postpartum with no supplementation for offspring; or SQ-LNSs until 6 mo postpartum, and SQ-LNSs for offspring (6 mg Fe/d) from 6 to 18 mo of age [the lipid-based nutrient supplement (LNS) group]. We assessed noninferiority (margin ≤20%) between any 2 groups during 0–6 mo of age, and between the non-LNS and LNS groups during 6–18 mo of age for caregiver-reported acute respiratory infection, diarrhea, gastroenteritis, fever/suspected malaria, poor appetite, and “other illnesses.” Results During 0–6 mo of age, 1197 infants contributed 190,503 infant-days. For all morbidity combined, overall mean incidence (per 100 infant-days) was 3.3 episodes, overall mean prevalence (percentage of infant-days) was 19.3%, and the 95% CIs of the incidence rate ratio (IRR) and longitudinal prevalence rate ratio (LPRR) between any 2 groups were ≤1.20. During 6–18 mo, there were 240,097 infant-days for the non-LNS group and 118,698 for the LNS group. For all morbidity combined, group mean incidences were 4.3 and 4.3, respectively (IRR: 1.0; 95% CI: 1.0, 1.1), and mean prevalences were 28.2% and 29.3%, respectively (LPRR: 1.0; 95% CI: 1.0, 1.1). Noninferiority was inconclusive for diarrhea, fever/suspected malaria, and poor appetite. Conclusions SQ-LNS consumption does not increase reported overall child morbidity in this population compared with the 2 other treatments. This trial was registered at clinicaltrials.gov as NCT00970866.

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Maternal and Infant Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Increases Infants’ Iron Status at 18 Months of Age in a Semiurban Setting in Ghana: A Secondary Outcome Analysis of the iLiNS-DYAD Randomized Controlled Trial

Journal of Nutrition ◽

10.1093/jn/nxy225 ◽

2019 ◽

Vol 149 (1) ◽

pp. 149-158 ◽

Cited By ~ 5

Author(s):

Seth Adu-Afarwuah ◽

Rebecca T Young ◽

Anna Lartey ◽

Harriet Okronipa ◽

Per Ashorn ◽

...

Keyword(s):

Folic Acid ◽

Low Income ◽

Iron Status ◽

Controlled Trial ◽

Geometric Mean ◽

Secondary Outcome ◽

Outcome Analysis ◽

Zinc Protoporphyrin ◽

Lower Prevalence ◽

Nutrient Supplements

ABSTRACT Background Interventions are needed to address iron deficiency in low-income settings. Objective This secondary outcome analysis aimed to compare the hemoglobin (Hb) and iron status [zinc protoporphyrin (ZPP)] of children born to women enrolled in the iLiNS-DYAD trial in Ghana. Methods Women ≤20 wk pregnant (n = 1320) were assigned to receive 60 mg Fe/d and 400 µg folic acid/d until delivery and placebo thereafter, and no supplementation for infants (IFA group); or multiple micronutrients containing 20 mg Fe/d until 6 mo postpartum and no supplementation for infants (MMN); or small-quantity lipid-based nutrient supplements (SQ-LNSs) containing 20 mg Fe/d until 6 mo postpartum, and SQ-LNSs for infants from 6 to 18 mo of age (LNS). We compared infants’ Hb (g/L) and ZPP (µmol/mol heme) at 6 and 18 mo of age. Results At 6 mo of age, groups did not differ in mean ± SD Hb (overall: 113 ± 9.9 g/L) or geometric mean (95% CI) ZPP [overall: 62.6 (60.6, 64.7)]. At 18 mo of age, mean ± SD Hb (overall: 112 ± 10.4 g/L) did not differ significantly between groups, whereas geometric mean (95% CI) ZPP was lower (P = 0.031) in the LNS group [53.9 (50.7, 57.3)] than the IFA [60.4 (56.7, 64.3)] but not the MMN [58.8 (55.6, 62.2)] group. Further, the LNS group, compared with the IFA and MMN groups combined, had a lower prevalence of elevated (>70) ZPP (27.5% compared with 35%; P = 0.02) and a marginally lower prevalence of anemia (38.7% compared with 44.9%; P = 0.06). These results generally remained unchanged when controlling for prespecified covariates or correcting for inflammation. Conclusions In this setting, providing SQ-LNSs or multiple micronutrients with 20 mg Fe/d, compared with iron (60 mg/d) and folic acid, to pregnant women does not affect their infants’ Hb or iron status at 6 mo of age, but maternal and infant supplementation with SQ-LNSs increases infants’ iron status at 18 mo of age. This trial was registered at clinicaltrials.gov as NCT00970866.

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Maternal–Infant Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Affect Child Blood Pressure at 4–6 Y in Ghana: Follow-up of a Randomized Trial

Journal of Nutrition ◽

10.1093/jn/nxy285 ◽

2019 ◽

Vol 149 (3) ◽

pp. 522-531 ◽

Cited By ~ 2

Author(s):

Sika M Kumordzie ◽

Seth Adu-Afarwuah ◽

Rebecca R Young ◽

Brietta M Oaks ◽

Solace M Tamakloe ◽

...

Keyword(s):

Blood Pressure ◽

Birth Weight ◽

Controlled Trial ◽

Intervention Group ◽

Path Model ◽

Secondary Outcome ◽

Double Blind ◽

Blood Institute ◽

Nutrient Supplements ◽

Pregnancy And Postpartum

ABSTRACT Background In the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD-Ghana trial, prenatal small-quantity lipid-based nutrient supplements (LNSs) had a positive effect on birth weight. Birth weight may be inversely related to blood pressure (BP) later in life. Objectives We examined the effect of the intervention on BP at 4–6 y of age, and maternal and child factors related to BP. Methods The iLiNS-DYAD-Ghana study was a partially double-blind, randomized controlled trial which assigned women (n = 1320) ≤20 weeks of gestation to daily supplementation with: 1) iron and folic acid during pregnancy and 200 mg Ca for 6 mo postpartum , 2) multiple micronutrients during pregnancy and postpartum, or 3) LNSs during pregnancy and postpartum plus LNSs for infants from 6 to 18 mo of age. At 4–6 y of age (n = 858, 70% of live births), we compared BP, a secondary outcome, between non-LNS and LNS groups and examined whether BP was related to several factors including maternal BP, child weight-for-age z score (WAZ), and physical activity. Results Non-LNS and LNS groups did not differ in systolic (99.2 ± 0.4 compared with 98.5 ± 0.6 mm Hg; P = 0.317) or diastolic (60.1 ± 0.3 compared with 60.0 ± 0.4 mm Hg; P = 0.805) BP, or prevalence of high BP (systolic or diastolic BP ≥90th percentile of the US National Heart, Lung, and Blood Institute reference: 31% compared with 28%; P = 0.251). BP at 4–6 y of age was positively related to birth weight; this relation was largely mediated through concurrent WAZ in a path model. Concurrent WAZ and maternal BP were the factors most strongly related to child BP. Conclusions Despite greater birth weight in the LNS group, there was no intervention group difference in BP at 4–6 y. In this preschool population at high risk of adult hypertension based on BP at 4–6 y, high maternal BP and child WAZ were key factors related to BP. This trial was registered at clinicaltrials.gov as NCT00970866.

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Effects of Prenatal and Postnatal Maternal Multiple Micronutrient Supplementation on Child Growth and Morbidity in Tanzania: A Double-Blind, Randomized Controlled Trial

Current Developments in Nutrition ◽

10.1093/cdn/nzab046_125 ◽

2021 ◽

Vol 5 (Supplement_2) ◽

pp. 828-828

Author(s):

Dongqing Wang ◽

Uma Chandra Mouli Natchu ◽

Anne Marie Darling ◽

Ramadhani Noor ◽

Ellen Hertzmark ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Child Growth ◽

Mean Difference ◽

Micronutrient Supplementation ◽

Z Score ◽

Double Blind ◽

Randomized Controlled ◽

Child Morbidity ◽

Multiple Micronutrient

Abstract Objectives Maternal micronutrient status is critical for child growth and nutrition. It is unclear whether maternal multiple micronutrient supplementation (MMS) during pregnancy and lactation improves child growth and prevents child morbidity. The aim of this study was to determine the effects of prenatal and postnatal maternal MMS on child growth and morbidity in Tanzania. Methods In this double-blind, randomized controlled trial, 8,379 HIV-negative pregnant women were enrolled from Dar es Salaam, Tanzania, between 2001 and 2004. From pregnancy (12 to 27 weeks of gestation) through 6 weeks postpartum, participants were randomized to receive daily oral MMS or placebo. All women received daily iron and folic acid during pregnancy. From 6 weeks postpartum through 18 months postpartum, 3,100 women were re-randomized to MMS or placebo. Child growth measures, hemoglobin concentrations, and infectious morbidities were assessed longitudinally from birth to up to 18 months. Linear mixed-effects models were used to estimate the effects of prenatal and postnatal MMS on child growth z-scores and hemoglobin concentrations. Cox proportional hazards models were used to estimate the effects on undernutrition. Generalized estimating equations were used to estimate the effects on anemia and infectious morbidities. Results Prenatal MMS led to modest increases in weight-for-age z-score (mean difference: 0.050; 95% CI: 0.002, 0.099; p = 0.04) and length-for-age z-score (mean difference: 0.062; 95% CI: 0.013, 0.111; p = 0.01) during the first six months of life but not thereafter. Prenatal MMS did not have significant benefits for anemia, morbidity, or other child growth outcomes. Postnatal MMS did not have significant benefits for any child outcomes. Conclusions While maternal MMS is a proven strategy to prevent adverse birth outcomes, other approaches may also need to be considered to curb the high burdens of child morbidity and growth faltering. Funding Sources This work was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health.

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Does perturbation-based balance training prevent falls among individuals with chronic stroke? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-021510 ◽

2018 ◽

Vol 8 (8) ◽

pp. e021510 ◽

Cited By ~ 28

Author(s):

Avril Mansfield ◽

Anthony Aqui ◽

Cynthia J Danells ◽

Svetlana Knorr ◽

Andrew Centen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Rate Ratio ◽

Daily Life ◽

Controlled Trial ◽

Balance Training ◽

Chronic Stroke ◽

Secondary Outcome ◽

Control Group ◽

Randomised Controlled ◽

And Control

ObjectivesNo intervention has been shown to prevent falls poststroke. We aimed to determine if perturbation-based balance training (PBT) can reduce falls in daily life among individuals with chronic stroke.DesignAssessor-blinded randomised controlled trial.SettingTwo academic hospitals in an urban area.InterventionsParticipants were allocated using stratified blocked randomisation to either ‘traditional’ balance training (control) or PBT. PBT focused on improving responses to instability, whereas traditional balance training focused on maintaining stability during functional tasks. Training sessions were 1 hour twice/week for 6 weeks. Participants were also invited to complete 2 ‘booster’ training sessions during the follow-up.ParticipantsEighty-eight participants with chronic stroke (>6 months poststroke) were recruited and randomly allocated one of the two interventions. Five participants withdrew; 42 (control) and 41 (PBT group) were included in the analysis.Primary and secondary outcome measuresThe primary outcome was rate of falls in the 12 months post-training. Negative binomial regression was used to compare fall rates between groups. Secondary outcomes were measures of balance, mobility, balance confidence, physical activity and social integration.ResultsPBT participants reported 53 falls (1.45 falls/person-year) and control participants reported 64 falls (1.72 falls/person-year; rate ratio: 0.85(0.42 to 1.69); p=0.63). Per-protocol analysis included 32 PBT and 34 control participants who completed at least 10/12 initial training sessions and 1 booster session. Within this subset, PBT participants reported 32 falls (1.07 falls/person-year) and control participants reported 57 falls (1.75 falls/person-year; rate ratio: 0.62(0.29 to 1.30); p=0.20). PBT participants had greater improvement in reactive balance control than the control group, and these improvements were sustained 12 months post-training. There were no intervention-related serious adverse effects.ConclusionsThe results are inconclusive. PBT may help to prevent falls in daily life poststroke, but ongoing training may be required to maintain the benefits.Trial registration numberISRCTN05434601; Results.

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Patient Education and Sacubitril/Valsartan: A Randomized Comparative Trial

Hospital Pharmacy ◽

10.1177/0018578721999808 ◽

2021 ◽

pp. 001857872199980

Author(s):

Christopher Giuliano ◽

Bradley St. Pierre ◽

Jamie George

Keyword(s):

Controlled Trial ◽

Comparative Trial ◽

Text Messages ◽

Phone Call ◽

Secondary Outcome ◽

Short Term ◽

Phone Calls ◽

Video Education ◽

Pharmacist Education

Objective: To compare video to pharmacist education for patients taking sacubitril/valsartan. Methods: We conducted a randomized controlled trial comparing video to pharmacist education with a second randomized intervention of education delivered through text or phone call at 14 days. The primary outcome compared the change in short term knowledge between groups and the secondary outcome was long term knowledge at 1 month. Results: Forty-three patients were included. Scores improved significantly ( P < .05) in the pharmacist group from 54.1% to 85.9% and from 64.3% to 86.1% in the video education group, although there was no difference between groups (31.8% vs 22.9%, P = .13). At 30 days, scores were significantly higher than baseline (difference 16.5%, P < .05) although did decrease from the posttest (difference 7.4%, P < .05). There was no difference at 30 days between those that received text messages versus phone calls (−10% vs −5.5%, respectively; P = .36). Conclusion: We saw improvements in both short term and long term knowledge for patients receiving education through pharmacist or video education. Neither approach was more effective than the other. Clinicians can use either approach based on patient preference.

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Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

International Urogynecology Journal ◽

10.1007/s00192-021-04739-5 ◽

2021 ◽

Author(s):

Kari Bø ◽

Lene Anette H. Haakstad ◽

Gøran Paulsen ◽

Anne Mette Rustaden

Keyword(s):

Randomized Controlled Trial ◽

Urinary Incontinence ◽

Strength Training ◽

Short Form ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Sum Score ◽

New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

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Metformin reduces 12-month change in body weight among people newly commenced on clozapine: a retrospective naturalistic cohort study

Therapeutic Advances in Psychopharmacology ◽

10.1177/20451253211000609 ◽

2021 ◽

Vol 11 ◽

pp. 204512532110006

Author(s):

Jessica Spokes ◽

Samantha Hollingworth ◽

Karl Winckel ◽

Steve Kisely ◽

Andrea Baker ◽

...

Keyword(s):

Cohort Study ◽

Weight Gain ◽

Tobacco Smoking ◽

Digital Health ◽

Controlled Trial ◽

Bodyweight Gain ◽

Metabolic Effects ◽

Secondary Outcome ◽

Standard Clinical Practice ◽

Randomised Controlled

Background: People with schizophrenia have a 15–20-year reduction in life expectancy, driven in part by the metabolic effects of antipsychotics. Clozapine is associated with the highest rates of weight gain. As clozapine remains the most effective antipsychotic for treatment-resistant schizophrenia (TRS), identifying treatments to ameliorate clozapine-induced weight gain (CIWG) is urgently needed to reduce this morality gap. Methods: We retrospectively analysed digital health records of patients with TRS aged 18–65 newly initiated on clozapine at four tertiary hospitals in south-east Queensland from 1 March 2017 to 30 June 2019. Our primary outcome was the effect of metformin on change in percentage bodyweight at 12 months after clozapine initiation, with secondary outcome being proportion with >5% or >7% bodyweight change. We also explored impact on bodyweight change of other variables including sex, tobacco smoking, type 2 diabetes (T2DM), age, clozapine level and dose and clozapine/norclozapine ratio. Results: Among 90 patients initiated on clozapine, metformin use ( n = 48) was associated with a smaller increase in percentage bodyweight (1.32% versus 5.95%, p = 0.031), lower rates of >7% gain in bodyweight (37.8% versus 63.0%, p = 0.025) but not >5% gain in bodyweight. Age below the median (32.0 years) was associated with greater bodyweight gain (5.55% versus 1.22%, p = 0.046). Sex, tobacco smoking, T2DM, clozapine dose and level and clozapine/norclozapine ratio were not associated with differences in change in bodyweight. Conclusion: In this small retrospective cohort study, use of metformin within 12-months of clozapine initiation was associated with a statistically and clinically significant reduction in CIWG. Although there is increasing evidence for the role of metformin to ameliorate bodyweight gain at time of clozapine initiation, our findings need replication and testing in a randomised controlled trial before recommending metformin co-commencement with clozapine as standard clinical practice.

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Efficacy and Safety of Divaza for the Correction of Oxidative Disturbances in Patients with Cerebral Atherosclerosis: A Randomized Controlled Trial

Cerebrovascular Diseases ◽

10.1159/000515233 ◽

2021 ◽

pp. 1-11

Author(s):

Nataliia U. Lashch ◽

Pavel R. Kamchatnov ◽

Tatiana N. Fedorova ◽

Olga A. Muzychuk ◽

Kristina K. Khacheva ◽

...

Keyword(s):

Cognitive Impairment ◽

Placebo Group ◽

Study Design ◽

Therapeutic Option ◽

Controlled Trial ◽

Prospective Trial ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Cerebral Atherosclerosis ◽

Endogenous Antioxidant

Objective: The objective of this study was to determine if Divaza, a drug with nootropic and antioxidant effects, was safe and effective for the correction of oxidative disturbances and to stabilize cognitive impairment in patients with cerebral atherosclerosis. Study Design: The study design consisted of a 12-week multicenter, randomized, double-blind, placebo-controlled, prospective trial in parallel groups. Setting: The setting in which the study was conducted comprised 10 clinical centers across the Russian Federation. Interventions: Patients were randomized into 2 groups and instructed to take either 2 tablets of the study drug or a placebo 3 times per day in conjunction with basic therapy. Outcomes: The primary outcome was a change in the average endogenous antioxidant potential after the completion of the study. The blood indicators of the oxidative stress (OS) were analyzed at the baseline and then after 12 weeks of therapy using iron-induced chemiluminescence analysis. The Montreal cognitive assessment test was used as a secondary outcome measure to evaluate cognitive impairment at the end of the study. Results: 124 outpatients with a mean age of 60.7 ± 7.6 years were enrolled and randomly assigned to receive Divaza (n = 65) or a placebo (n = 59). An improvement of cognitive function was observed in all patients of the Divaza group at the end of the treatment; this was significantly better than the placebo group (100 [100] vs. 89.5 [89.1]%, respectively, p = 0.0272 [p = 0.0128]). The administration of Divaza restored the activity of the endogenous antioxidant system. The change in the average level of lipoprotein resistance to oxidation after 12 weeks of therapy, compared to the baseline, was significantly higher in the Divaza group (14.8 ± 14.7 [14.8 ± 14.7] seconds latent period vs. 6.4 ± 16.9 [6.9 ± 16.7] seconds in the placebo group (p = 0.007 [p = 0.0107]). Conclusions: Divaza is a safe and effective therapeutic option for attenuating OS and recovery of cognitive impairment in patients with cerebral atherosclerosis.

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PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽

10.1136/bmjopen-2021-050582 ◽

2021 ◽

Vol 11 (6) ◽

pp. e050582

Author(s):

Annette Mollerup ◽

Sofus Christian Larsen ◽

Anita Selmer Bennetzen ◽

Marius Henriksen ◽

Mette Kildevaeld Simonsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Hospital Admission ◽

Usual Care ◽

Pulmonary Disease ◽

Controlled Trial ◽

Self Care ◽

Secondary Outcome ◽

Link Type ◽

Randomised Controlled ◽

At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

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The effects of nano-curcumin as a nutritional strategy on clinical and inflammatory factors in children with cystic fibrosis: the study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05224-6 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Saeedeh Talebi ◽

Mahammad Safarian ◽

Mahmood Reza Jaafari ◽

Seyed Javad Sayedi ◽

Zahra Abbasi ◽

...

Keyword(s):

Cystic Fibrosis ◽

Controlled Trial ◽

Genetic Disorder ◽

The Body ◽

Inflammatory Factors ◽

Secondary Outcome ◽

Nasopharyngeal Swab ◽

Nutritional Strategy ◽

Cftr Protein ◽

The Impact

Abstract Background Cystic fibrosis (CF) is a genetic disorder, which is caused by the CFTR protein defects. Along with CFTR dysfunction, inflammation plays a key role in the disease outcomes. Inflammation may develop due to the internal dysfunction of the CFTR protein or external factors. Curcumin affects the CFTR protein function primarily as a corrector and potentiator and secondary as an anti-inflammatory and antimicrobial agent. The present study aims to assess the impact of nano-curcumin on clinical and inflammatory markers in children with CF. Methods This prospective, double blind control trial will be conducted at the Akbar Children’s Hospital in Mashhad, Iran. Children with CF will be enrolled based on the eligibility criteria. Placebo and curcumin with the maximum dose of 80 mg considering the body surface of the patients will be administrated for 3 months. The primary outcome is to evaluate inflammation based on serum interleukin-6, interleukin-10, and hs-CRP, stool calprotectin, and neutrophil count of nasopharyngeal swab. The secondary outcome involved clinical assessment via spirometry, anthropometrics, and quality of life. They will be assessed before and after 3 months. Discussion Due to the multifarious effects of curcumin on CF disease, it could be proposed as a nutritional strategy in the treatment of cystic fibrosis. Trial registration Iranian Registry of Clinical Trials IRCT20200705048018N1. Registered on July 10, 2020.

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