Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Young Children: An Individually Randomized, Parallel-Group, Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,568
- 试验地点
- 2
- 主要终点
- Stunting
研究概览
简要总结
Nutrition is essential for a child's growth, brain development, and protection from disease. While breastmilk provides the best nutrition for young infants, children older than six months may not get all the nutrients they need from breastmilk and regular foods alone. For this reason, some children receive special nutrient supplements to support healthy growth.
Lipid-based nutrient supplements (LNS) are one type of supplement that provides important vitamins and minerals. These supplements are used in many countries to help prevent undernutrition in young children. In Pakistan, the government-led multisectoral nutrition program under the social safety net program currently provides medium-quantity LNS to children starting at six months of age. However, it is not known whether a smaller-quantity LNS could provide similar benefits for children in this age group from under-resourced communities that have limited access to nutritious foods.
The goal of this trial is to learn whether small-quantity lipid-based nutrient supplements (SQ-LNS) work as well as medium-quantity lipid-based nutrient supplements (MQ-LNS) in preventing undernutrition in children aged 6 to 12 months.
The main questions this study aims to answer are:
- Does SQ-LNS work as well as MQ-LNS in supporting healthy growth, including reducing stunting, wasting, and underweight?
- Does SQ-LNS work as well as MQ-LNS in reducing anemia?
Researchers will compare SQ-LNS and MQ-LNS to see if SQ-LNS is as good as MQ-LNS in preventing undernutrition.
The study is being conducted in Dadu and Peshawar, Pakistan. Participants will be followed until 12 months of age.
Participants will:
- Receive either SQ-LNS or MQ-LNS once daily until 12 months of age
- Have their length, weight and mid-upper arm circumference (MUAC) measured monthly
- Have their blood screened for anemia at enrollment and at 12 months of age
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
盲法说明
The statistical analysis team will remain blinded to the intervention allocation to minimize the risk of bias.
入排标准
- 年龄范围
- 26 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 months (26 weeks) to 7 months and 15 days (33 weeks) with weight-for-length z-score (WLZ) ≥ -2 standard deviation (SD) and mid-upper arm circumference (MUAC) ≥125 mm, born to mothers who are beneficiaries of the Benazir Income Support Programme and registered with the Benazir Nashonuma Programme (BNP) at any point during their pregnancy.
- •Permanent residents of the selected districts, with no plan to relocate or migrate within the next 6 months.
- •Written informed consent provided by the child's caregivers.
排除标准
- •Children with moderate acute malnutrition (MAM), defined as WLZ ≥ -3 to < -2 SD, or MUAC ≥115 mm to <125 mm.
- •Children with severe acute malnutrition (SAM), defined as WLZ < -3 SD or MUAC <115 mm or presence of bilateral pitting edema, who require therapeutic feeding.
- •Children with known congenital anomalies, chronic illness, or conditions affecting growth or feeding (for example, cerebral palsy or congenital heart disease).
- •Children already enrolled in any nutritional supplementation other than BNP or another clinical trial.
- •Children whose families will be unwilling to provide informed consent, or likely to be unavailable for follow-up.
研究组 & 干预措施
Medium-quantity lipid-based nutrient supplement (MQ-LNS)
Children receiving MQ-LNS
干预措施: Medium-quantity lipid-based nutrient supplement (MQ-LNS) (Dietary Supplement)
Small-quantity lipid-based nutrient supplement (SQ-LNS)
Children receiving SQ-LNS
干预措施: Small-quantity lipid-based nutrient supplement (SQ-LNS) (Dietary Supplement)
结局指标
主要结局
Stunting
时间窗: Monthly from enrollment to the end of intervention period at 6 months
length-for-age z-score (LAZ) \< -2 SD
次要结局
- Prevalence of anemia(At enrollment and later at the end of intervention period at 6 months)
- Wasting(Monthly from enrollment to the end of intervention period at 6 months)
- Underweight(Monthly from enrollment to the end of intervention period at 6 months)
- Morbidity(Monthly from enrollment to the end of intervention period at 6 months)
研究者
Dr Shabina Ariff
Professor Shabina Ariff
Aga Khan University