Effect of daily therapeutic supplementation with multiple micronutrients and iron folic acid compared to iron folic acid alone in mild to moderate anemic children aged 6 to 59 months on anaemia cure and haemoglobin concentration: A randomized controlled trial in rural Haryana
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Mean haemoglobin concentration
研究概览
简要总结
The proposed individually randomized open label trial aims to evaluate the effect of daily supplementation, for 90 days, of erythropoiesis-relevant micronutrients (zinc, vitamins B1, B3, B5, B2, B12, B6, A, C, E and D) in addition to iron folic acid (IFA) in comparison with IFA alone, in children aged 6 to 59 monthswith mild to moderate anaemia, on anaemia cure rate and haemoglobin concentration. Other outcomes (secondary outcomes) will be assessed in a sub-sample of study children and include serum ferritin, serum transferrin receptor, total iron binding capacity, percent transferrin saturation, micronutrient levels and levels of inflammatory markers (hs-CRP). We also propose to perform a cost effectiveness analysis.Micronutrient (Serum Vitamin B12, Zinc and Folate) levels in blood and proportion deficient, serum hepcidin and hs-CRP will be assessed in a randomly selected sub-sample of children at baseline. The study question emerged from a national consultation facilitated by the Indian Council of Medical Research (ICMR), an apex body in India for formulation, coordination and promotion of biomedical research, because of the growing concern of the national government that the rate of decline in burden of childhood anemia is quite slow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 59.00 Month(s)（—）
- 性别
- All
入选标准
- •Children aged 6-59 months, residing in rural areas of Palwal district, with mild to moderate anaemia
- •Children who are aged 6-59 months
- •Mild to moderate anaemia at enrolment (Hb ≥7 g/dl and <11g/dl)
- •Consent to participate in the study.
排除标准
- •No Anemia (Hb ≥11g /dL)
- •Severe anemia (Hb <7g/dL)
- •Documented haemoglobinopathy
- •History of repeated blood transfusions and chronic or systemic illnesses
- •Mid-upper arm circumference (MUAC) of <11.5cm
- •Family do not intend to stay in the study area for the duration of the intervention.
结局指标
主要结局
Mean haemoglobin concentration
时间窗: The outcomes will be measured around a week after completion of 90 days supplementation period
Proportion of children cured of anemia (i.e. Hb ≥11 g/dl)
时间窗: The outcomes will be measured around a week after completion of 90 days supplementation period
次要结局
- Laboratory parameters in a sub-sample(1. Serum ferritin (ng/ml))
- Cost-effective analysis of supplementing iron folic acid with multiple micronutrients compared to iron folic acid alone(The analysis will be conducted once the supplementation period of 90 days is over and data on outcomes are available)