Prevention of Linear Growth Failure in Infants and Young Children With Lipid-based Nutrient Supplements (iLiNS-DOSE)

Phase 3

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Lipid-based nutrient supplement, 40gM; Dietary Supplement: Lipid-based nutrient supplement, 10gM; Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM; Dietary Supplement: Lipid-based nutrient supplement, 20gM; Dietary Supplement: Maize-soy flour; Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM

• Registration Number: NCT00945698
• Lead Sponsor: Tampere University

Brief 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 infants and their guardians in Malawi and Ghana. In the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the investigators will test a hypothesis that LNS that does not contain milk promotes growth as well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural Malawi.

Detailed Description

Six-month old healthy infants are identified through community surveys in the study area. 1920 infants meeting set criteria are randomised into receiving the following intervention between 6 and 18 months of age: 1) standard treatment from 6-18 months (i.e.no supplements, with delayed intervention between 18-30 months of age (ST-DI), 2) 10 g / day milk-containing LNS (LNS-10gM), 3) 20 g / day milk-containing LNS (LNS-20gM), 4) 20 g / day milk-free LNS (LNS-20gNoM), 5) 40 g / day milk-containing LNS, (LNS-40gM) 6) 40 g / day milk-free LNS (LNS-40gNoM). The families receive the food supplements at 2-weekly intervals and the participants undergo a morbidity evaluation weekly, a limited development assessment at 4-weekly intervals and anthropometric evaluation at 26-week intervals and laboratory analyses at enrollment and at 18 months. Growth outcome analyses are done at 18 and at 42 months of age.

Study Timeline

• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-24
• Study Start: 2009-11
• Primary Completion: 2012-08
• Study Completion: 2014-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1920

Inclusion Criteria

• Signed informed consent from at least one guardian
• Age 5.50 months to 6.49 months
• Availability during the period of the study.
• Permanent resident of Mangochi District Hospital or Namwera Health Centre catchment area

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Exclusion Criteria

• Weight for length Z score (WLZ) < -2.0
• Presence of oedema
• Severe anaemia (Hb<50 g / l)
• Severe illness warranting hospital referral
• History of allergy towards peanut
• History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
• Concurrent participation in any other clinical trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNS-40gM	Lipid-based nutrient supplement, 40gM	* 560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
LNS-10gM	Lipid-based nutrient supplement, 10gM	* 140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
LNS-40gNoM	Lipid-based Nutrient Supplement, 40gNoM	* 560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
LNS-20gM	Lipid-based nutrient supplement, 20gM	* 280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
ST-DI (Delayed intervention)	Maize-soy flour	* 1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
LNS-20gNoM	Lipid-based Nutrient Supplement, 20gNoM	* 280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

Primary Outcome Measures

Name	Time	Method
Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age	Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)
Incidence of serious adverse events during the study period	12 months after enrollment (age 18 months)

Secondary Outcome Measures

Name	Time	Method
Energy intake from complementary foods	3 and 9 months after enrollment (age 9 and 15 months)
Change in weight-for-age (WAZ) and weight-for-length (WLZ) Z-scores	Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)
Immune function (measured by humoral immunity towards measles vaccination)	12 months after enrollment (age 18 months)
Proportion with anaemia at 18 months of age	12 months after enrollment (age 18 months)
Neuro-behavioral development (timing of acquisition of the certain skills and more comprehensive analysis at the age of 18 months)	Limited assessment every 4 weeks during the 12 months supplementation, more comprehensive at age 18 months
Incidence of stunting, underweight, and wasting	Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)
Prevalence of reduced appetite	Daily assessment during 12 month supplementation
Incidence of caregiver-reported morbidity	Daily assessment during 12 month supplementation
Incidence of laboratory-confirmed malaria infection	12 months after enrollment (age 18 months)
Change in hemoglobin and micronutrient status (iron status, measured by zinc protoporphyrin (ZPP); plasma zinc; plasma vitamin A; B-vitamins and related metabolites; urine iodine	12 months after enrollment (age 18 months)
Change in erythrocyte essential fatty acid (EFA) concentration (measured from a subsample of 400 participants)	12 months after enrollment (age 18 months)
Incidence of all adverse events during the study period	12 months after enrollment (age 18 months)

Trial Locations

Locations (1)

University of Malawi, College of Medicine; 🇲🇼 Mangochi, Malawi