Role of L-Carnitine Supplementation on Rate of Weight Gain and Biomarkers of Environmental Enteric Dysfunction (EED) in Children With Severe Acute Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Rate of weight gain
研究概览
简要总结
Background:
Burden:
Globally, an estimated 14.3 million under-5 children are severely malnourished. Two-thirds of them live in Asian countries, including Bangladesh. Acute malnutrition is an underlying cause of nearly half of global deaths in under-5 children despite standardized rehabilitation protocols. It is also associated with high relapse rates following discharge.
Knowledge Gap:
Malnourished children suffer from deficiencies of several essential nutrients. Studies showed that malnourished children had lower serum carnitine levels and demonstrated its role in the rate of weight gain in children with severe acute malnutrition (SAM). The consequences of nutritional impairment can be perilous if carnitine deficiency is coupled with Environmental Enteric Dysfunction (EED). Recent evidence confirms that EED is characterized by secondary carnitine deficiency in children. Carnitine deficiency leading to EED may cause childhood growth faltering and impaired cognitive development. However, evidence on carnitine status and its consequences in relation to EED in diarrheal children with SAM is very limited in Bangladesh.
Relevance:
Such lack of information regarding the role of L-carnitine in improving the rate of weight gain in malnourished children susceptible to EED is an obstacle in limiting the relapse and adverse consequences of SAM in diarrheal children living in resource-limited countries.
Hypothesis: L- carnitine supplementation for 15 days in children with SAM will improve the rate of weight gain and biomarkers of EED
Objective:
- To investigate the role of L-carnitine supplementation on the rate of weight gain among the children with SAM
- To investigate the role of L-carnitine supplementation on the duration of the hospital stays
- To examine the role of L-carnitine supplementation on EED biomarkers, for instance, myeloperoxidase (MPO), neopterin (NEO), alpha-1 anti-trypsin (A1AT), kynurenine: tryptophan (KT) ratio, and citrulline in children with SAM
Methods: This study will be a double-blinded, placebo-controlled randomized clinical trial
详细描述
Study Design:
Study Site:
This study will be done in the Dhaka Hospital at icddr,b.
Study population:
In this study, the investigator will enroll diarrheal children with SAM aged 9-24 months of both genders attending longer stay units (LSU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 9 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diarrheal children with SAM aged 9-24 months
- •Signed informed consent by the guardian/caregivers
排除标准
- •Severe sepsis or Septic shock
- •Patients already taking medications containing L- carnitine
- •Children with Tuberculosis
- •Children with congenital defects or chromosomal anomalies
- •Children with a diagnosed case of Thalassemia
- •Children with an active or previous history of convulsion
研究组 & 干预措施
Intervention Arm
Children randomized to this arm will receive L- carnitine oral solution (100mg/ml) (Generic Name) with the dosage- 100 mg/kg/day, divided into 3 doses per day for 15 days.
干预措施: L- carnitine oral solution (Drug)
Control Arm
Children randomized to this arm will receive placebo in same quantity, divided into 3 doses per day for 15 days.Placebo solution will be identical in appearance, smell and taste to the active preparation (L-carnitine syrup) with no therapeutic value.
干预措施: Placebo (Other)
结局指标
主要结局
Rate of weight gain
时间窗: Baseline to 15th day of treatment
The rate of weight gain (g/kg/day) will be calculated by using the formulae below: \[{Weight on completion of study - Weight on enrolment (or at no edema) (g)} / {Total duration (in days) \* weight on enrolment in kg}\]
次要结局
- Duration of hospital stays(Baseline to 15 days of treatment)
- EED biomarkers [myeloperoxidase (MPO), neopterin (NEO), alpha-1 anti-trypsin (A1AT), kynurenine: tryptophan (KT) ratio, and citrulline](Baseline to 15 days of treatment)