Routine Administration of Folic Acid and Vitamin B12 to Prevent Childhood Infections in Young Indian Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia)
研究概览
简要总结
Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or without simultaneous administration of vitamin B12 reduces the rates of acute lower respiratory tract infections (ALRI), clinical pneumonia and diarrhea.
Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months will be identified through a survey. Eligible and willing Children aged 6-30 months will be randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child weight and length taken. The baseline blood samples will be collected. The supplements will be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by field workers.
详细描述
Pneumonia and diarrhea are among the leading causes of poor health and death in young children of developing countries.
Many of these children have inadequate intakes of several vitamins and minerals. Folate and vitamin B12 are important for normal function of the immune system. Deficiencies of these vitamins are often part of general malnutrition and might be responsible for the excess morbidity and mortality seen in malnourished children. In a recent cohort study in almost 2,500 Indian children we demonstrated that those with poor folate status had higher rates of diarrhea and pneumonia. This study also showed that children that were not breastfed had poor folate status and our analyses suggested that the effect of breastfeeding in preventing respiratory and gastrointestinal infections could be explained by the folate content of breast milk. The finding that poor folate status is related to increased susceptibility to childhood infections needs to be confirmed in well conducted clinical trials in populations where folate deficiency is prevalent.
This trial aims to examine whether daily supplementation of 2 recommended doses of folate or vitamin B12 or both will lessen the incidence of acute lower respiratory tract infections and diarrhea. We will also measure if the supplementation improves the weight and length of supplemented children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 6 to 30 months
- •Either sex
- •Likely to reside in area for next 6 months
排除标准
- •Severe systemic illness requiring hospitalization
- •Severe malnutrition, i.e. weight for height < -3 z of the WHO standard for this age group. For ethical reasons these children require micronutrient supplementation and adequate medical care.
- •Non consent
- •Consuming vitamin supplements that include folic acid and vitamin B
- •Severe anemia (Hb < 7 g/dL).
结局指标
主要结局
Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia)
时间窗: 6 months
Prevalence of diarrhea
时间窗: 6 months
次要结局
- Adverse events (vomiting and gastric discomfort)(6 months)
- Growth (length for age, weight for age, and length for weight)(6 month)
- Changes in folate, vitamin B12, methyl malonic acid, and homocysteine concentration(6 months)
- Compare the change in plasma MBL between the intervention groups(6 months)
- Vitamin D status(Baseline blood samples)
- Developmental Milestones(End study, i.e. after 6 months of vitamin B12 and/or folic acid administration)
- Measure the association between pneumonia incidence and the plasma mannose binding lectin (MBL) concentration(Baseline blood samples)
- Measure the exposure to Cryptosporidium spp(Baseline blood samples)
- Measure the association between the antibody response to Cryptosporidium and plasma MBL(Baseline blood samples)
- Vitamin D status and the risk for respiratory infections(Baseline samples and 6 months follow up)
研究者
Tor A. Strand
Professor II
Centre For International Health