Role of L-Carnitine supplementation on rate of weight gain and biomarkers of Environmental Enteric Dysfunction in children with severe acute malnutrition: A protocol for a double-blinded randomized controlled trial.
- 2022-09-30
- PloS one 17(9)
- Jinat Alam
- Md Ridwan Islam
- Shah Mohammad Fahim
- Md Amran Gazi
- Tahmeed Ahmed
- PubMed: 36178918
- DOI: 10.1371/journal.pone.0275291
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- diarrheal children with SAM between 9-24 months of both sexes attending the nutritional rehabilitation unit (NRU) of Dhaka Hospital of icddr,b
- Methods
- double-blinded, placebo-controlled, randomized clinical trial, two arms: L-carnitine supplementation or placebo for 15 days in addition to existing standard treatment of SAM
- Blinding
- Double-blind
- Duration
- 15 days
- Funding
- Unclear
Background
Severe acute malnutrition (SAM) and environmental enteric dysfunction (EED) are highly prevalent among children residing in resource-limited countries like Bangladesh. L-carnitine may play a role in improving the growth and ameliorating the EED among nutritionally vulnerable children.Objective
To investigate the role of L-carnitine supplementation on the rate of weight gain, duration of hospital stays, and EED biomarkers among children with severe acute malnutrition.Methods
This study is a double-blinded, placebo-controlled, randomized clinical trial aiming to enroll diarrheal children with SAM between 9-24 months of both sexes attending the nutritional rehabilitation unit (NRU) of Dhaka Hospital of icddr,b. It is an ongoing trial including two arms where one arm receives L-carnitine supplementation, and the other arms receive a placebo for 15 days in addition to the existing standard treatment of SAM. The primary outcome is the rate of weight gain, and the secondary outcomes include duration of hospital stay and EED biomarkers. Outcomes are assessed at baseline and 15 days of post-intervention. We hypothesize that the L- carnitine supplementation for 15 days in children with SAM will improve the rate of weight gain and biomarkers of EED.Trial registration
ClinicalTrials.gov # NCT05083637. Date of registration: October 19, 2021.Research Insights
secondary outcomes include ... EED biomarkers ... hypothesize that the L-carnitine supplementation for 15 days in children with SAM will improve ... biomarkers of EED
- Effect
- Beneficial
- Effect size
- Small
primary outcome is the rate of weight gain ... hypothesize that the L-carnitine supplementation for 15 days in children with SAM will improve the rate of weight gain
- Effect
- Beneficial
- Effect size
- Small
secondary outcomes include duration of hospital stay ... hypothesize that the L-carnitine supplementation for 15 days in children with SAM will improve ... biomarkers of EED
- Effect
- Beneficial
- Effect size
- Small