Clinical Trial

Supplementing Maternal and Infant Diet With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)

Study acronym: iLiNS-DYAD-M

Active, Not Recruiting Phase 3

Summary

The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating women and their infants from 6 to 18 months of age. In control groups, participants will receive either iron+folate tables during pregnancy only or multiple micronutrient tablets during pregnancy and first six months of lactations. The main hypothesis to be tested suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and the first 6 months of lactation is higher than the mean LAZ score of same age infants who received no dietary supplements and whose mothers received iron-folate supplementation during pregnancy only. To detect the long-term effect of the LNS supplementation, we now propose to conduct a follow-up study when the children are 9 years old, to see if the intervention had effect on children's growth, cardiometabolic and respiratory status and neurocognitive development.

Protocol Amendment History 10 amendments

This ClinicalTrials.gov record has been amended 10 times since 2010-11-10; most recent amendment 2025-03-24.

Status change: Completed → Active, Not Recruiting 2021-03-11

Status change: Active, Not Recruiting → Completed 2016-05-11

Status change: Recruiting → Active, Not Recruiting 2014-02-02

Status change: Not Yet Recruiting → Recruiting 2011-02-22

Trial Details

NCT Number	NCT01239693
Lead Sponsor	Tampere University Collaborators: Kamuzu University of Health Sciences, University of California, Davis, Bill and Melinda Gates Foundation, Finnish Institute for Health and Welfare, University of Oulu
Conditions	Infant Malnutrition, Malnutrition in Pregnancy
Enrollment	1,391 participants
Start Date	2011-02
Primary Completion	2015-04 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-03-28