Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra
试验速览
- 阶段
- 不适用
- 入组人数
- 649
- 试验地点
- 6
- 主要终点
- Child developmental Milestones achieved
研究概览
简要总结
The overall aim of the research is to conduct a randomised controlled trial of KOKOPlus in young HIV exposed children attending HIV clinics in Accra, Ghana to test the effectiveness of KOKOPlus over a period of 6 months to improve nutritional status and child development in HIV exposed children 6-18 months of age in Accra
详细描述
The specific objectives are to accomplish the following
- To test the effectiveness of KOKOPlus to improve the nutritional status of HIV exposed infants aged 6-18 months.
- To measure and compare nutritional status in intervention and control arms by monitoring growth in terms of height and weight over the period of 6 months
- To measure and compare micronutrient status of intervention and control arms by comparing baseline midline and endline measurements of hemoglobin levels.
- To measure and compare morbidity rates of intervention and control arms.
- To measure and compare rates of achievement of child development goals between intervention and control arms using a standardized tool, the Caregiver Reported Early Development Instrument (CREDI).
- To understand and record experiences relating to the use of KOKOPlus of mothers/caregivers in the intervention arm through focus group discussion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother-infant dyads; HIV positive mothers and children between 6 and 12 months of age attending antiretroviral (ART) Clinics and child HIV Clinics.
排除标准
- •Mothers who decline to participate in the study
- •Children with severe acute malnutrition (mid-upper arm circumference <115 mm or a weight-for-height/length <-3 Z-scores of the WHO growth standards).
- •Children on hospital admission
- •Children with diagnosed or apparent congenital conditions such as encephalitis, cleft palate, hole in heart, which negatively affect the child's ability to eat and/or growth.
研究组 & 干预措施
Intervention
KOKOPlus protein and micronutrient powder , a complementary food supplement containing soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix was formulated. Two weeks' supply of KOKOPlus sachets will be given to intervention arm participants every fortnight for 6 months to be mixed into any cereal, soup, stew, or other food given to the children.
干预措施: KOKOPlus protein and micronutrient powder (Dietary Supplement)
Control
This arm will receive no supplement and no placebo for the duration of the study.,
结局指标
主要结局
Child developmental Milestones achieved
时间窗: 6 months
Anthropometry
时间窗: 6 months
Length-for-age Z score, Weight-for-age Z score. Weight for length Z score
Haemoglobin
时间窗: 6 months
(g/dl), anaemia
次要结局
- Morbidity(6 months)