Efficacy of Lipid-based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,499
- 试验地点
- 4
- 主要终点
- Maternal primary outcome is child length at birth
研究概览
简要总结
In Ghana, low micronutrient intakes among pregnant women are a major problem. The standard nutritional intervention during pregnancy is iron-folic acid tablets, but adherence is low. The investigators have pioneered the use of multiple micronutrient-fortified semi-solid pastes called Lipid-based Nutrient Supplements (LNS) (made using vegetable oil, groundnut, milk, sugar, and micronutrients), and the investigators' previous studies show that the approach could have great potential for use by pregnant and lactating women.
This study aims to evaluate the effects of LNS-P&L designed for pregnant and lactating women and LNS-20gM designed for infants. Pregnant women (n=864) randomly selected from ante-natal clinics in Yilo and Manya Krobo districts of Ghana will be randomized to receive daily (a) Group 1: Iron/ Folic Acid tablets during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation (6 mo), (b) Group 2: Multiple Micronutrient tablets during pregnancy and the first six months of lactation, or (c) Group 3: LNS-P&L during pregnancy and lactation, whilst their infants receive LNS-20gM daily from 6 to 18 months. There are two primary outcomes namely:
- Maternal primary outcome: Birth length
- Child primary outcome: Child length-for-age z-score at 18 mo.
The investigators hypothesize that a) mean birth length and length-for-age at 18 mo will be greater in children whose mothers are in Group 2 than those whose mothers are in Group 1, and b) children whose mothers are in Group 3 will have greater birth length and length-for-age at 18 mo than the children in either of the other two groups.
详细描述
Introduction:
Inadequate nutrient intakes during pregnancy remain a major problem worldwide. The standard nutritional intervention during pregnancy is iron-folic acid tablets, but adherence is generally quite low. We have pioneered the use of lipid-based nutrient supplements (LNS), which are multiple micronutrient-fortified semi-solid pastes made using vegetable oil, groundnut paste, milk, sugar, and micronutrients, for home fortification of complementary foods for infants. Given results of previous studies with Nutributter in Ghana (1, 2) and similar LNS in Malawi (3, 4) we believe that the food-based approach using LNS has the potential to improve the nutritional status of these women, and thereby also enhance their children's growth and micronutrient status.
Our consortium has formulated LNS-P&L for pregnant and lactating women, and modified the Nutributter for children, which has been called LNS-20gM in this trial. The LNS-20gM provides generally the Recommended Nutrient Intakes (RNI) for 18 vitamins and minerals for infants from 6 to 18 mo of age. The LNS-P&L is modeled on the UNICEF/WHO/UNU international multiple micronutrient preparation (UNIMMAP) for pregnant and lactating women and similar products used in Guinea Bissau (5). Each supplement (20 g/day) will provide 118 kcal/day. Both LNS products (LNS-P&L and LNS-20gM) will, in addition to the multiple micronutrients provided in the MMN, supply energy (118 kcal/d), fat (11 g/d), protein (2.6 g/d), the essential fatty acids linoleic acid (=1.29 g/d) and a-linolenic acid (0.29 to >0.6 g/d), as well as calcium, phosphorus, potassium and magnesium.
Objectives
The study has two objectives, which are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •No more than 20 wk of gestation
- •Given Ante-natal Cards of the Ghana Health Service
- •Completed the initial routine ante-natal examination at the clinics
- •HIV negative or status unknown (as from the Ante-natal card)
- •Free from chronic disease e.g. malignancy requiring frequent medical attention (as from the Ante-natal card)
- •Residing in the Manya Krobo or Yilo Krobo district
- •Prepared to sign an informed consent
- •Living in the area throughout the duration of the study
- •Acceptance of home visitors
排除标准
- •Known asthmatic or history of allergy towards peanut or milk products
- •Concurrent participation in another clinical trial
- •Severe illness warranting hospital referral
结局指标
主要结局
Maternal primary outcome is child length at birth
时间窗: 0 - 48 hr after birth
Child primary outcome is child length-for-age Z-score (LAZ, based on WHO 2006 growth standards) at 18 months of age
时间窗: 18 months after birth
次要结局
未报告次要终点