Efficacy of Lipid-Based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants

Summary

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:

1. Maternal primary outcome: Birth length
2. 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.

Conditions

• Anemia
• Malnutrition
• Stunting

Interventions

DIETARY_SUPPLEMENT

Iron and Folic Acid (IFA)

Pregnant women will receive one (1) Iron (60 mg) and Folic Acid (400 mcg) (IFA) tablet daily during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation; there will be no supplementation for infants born to the women. The Fe/FA tablets will be taken each day with water after meals

DIETARY_SUPPLEMENT

Multiple Micronutrient (MMN) group

Pregnant women will receive one (1) Multiple Micronutrient tablet daily during pregnancy and the first 6 months of lactation; there will be no supplementation for infants born to the women. The MMN tablets will be taken each day with water after meals

DIETARY_SUPPLEMENT

Lipid-based Nutrient Supplements (LNS) group

Pregnant women will receive 20 g of LNS-P\&L daily during pregnancy and the first 6 months of lactation, whilst infants born to the women will receive 20 g of LNS-20gM daily from 6 to 18 mo of age. The LNS products (LNS-P\&L and LNS-20gM) will be consumed by being added to prepared food (usually mixed with complementary foods, for the child). Mothers will consume the full sachet of LNS (20 g/day) at one meal each day. Dosage and directions for use of the LNS product for children will be as follows: 20 g (\~4 teaspoons) per day divided into 2 portions and consumed at two different times of the day (2 x 2 teaspoons). Mix the portion of the supplement to be consumed with 2-3 tablespoons of the already prepared food (as done previously in our study in Ghana (1)), and eat the mixture before eating the rest of the food. Do not cook food with the supplement. Store supplement at room temperature. There is no need for refrigeration.

Sponsors & Collaborators

• University of California, Davis

  lead OTHER

Principal Investigators

• Kathryn G. Dewey, PhD · UC Davis

• Anna Lartey, PhD · +233 21 513294

• Seth Adu-Afarwuah, PhD · University of Ghana

• Elizabeth L Prado, PhD · University of California, Davis

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2017-12-15

Completion

2017-12-15

Countries

• Ghana

Study Locations