Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants

Phase 3

Completed

• Conditions: Malnutrition; Stunting; Developmental Delay
• Interventions: Dietary Supplement: Maize-soy flour; Dietary Supplement: Milk-containing fortified spread; Dietary Supplement: Soy-containing fortified spread

• Registration Number: NCT00524446
• Lead Sponsor: Tampere University

Brief Summary

This study tests the hypothesis that infants receiving milk-powder containing fortified spread (lipid-based nutrient supplement) as a complementary food for one year have lower incidence of severe stunting (poor length gain) than infants who are provided with no extra food supplements or maize-soy flour for complementary porridge.

Detailed Description

Poor growth and severe childhood stunting is very common in rural Malawi and elsewhere in Sub-Sahara Africa. To date, few interventions have proven successful in promoting linear growth in early childhood. Our preliminary results from Malawi suggest that a year-long daily complementary feeding of infants with a high-energy, micronutrient-fortified spread (FS) may markedly reduce the incidence of severe stunting before the age of 18 months. In the present study the investigators will more carefully analyze the efficacy in linear growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age.

The study will be conducted in Lungwena area, Mangochi District, rural Malawi. Six-month old healthy infants are identified through community surveys in the study area. 840 infants meeting set criteria are randomized into receiving the following intervention between 6 and 18 months of age: 1) standard treatment ie no extra food supplements (but dietary supplementation between 18 and 30 months of age) (ST-DI, control group), 2), "standard" fortified spread with milk-powder as the protein source (FSm), 3) modified fortified spread with soy-powder as the protein source (FSs), or 4) fortified maize-soy flour (likuni phala, LP). The families receive the food supplements at 2-weekly intervals and the participants undergo an anthropometric and developmental evaluation and laboratory analyses at 12-week intervals. Outcome analyses are done at 18 and at 36 months of age.

The impact of the dietary interventions will be primarily assessed by comparing the incidence of severe stunting in the four study groups. Secondary outcomes include a number of anthropometric variables, morbidity, developmental milestones, and laboratory parameters. The study will also produce descriptive data on possible mechanisms for growth failure among the trial subjects.

Study Timeline

• Study First Submitted: 2007-08-31
• Study First Submitted QC: 2007-08-31
• Study First Posted: 2007-09-03
• Study Start: 2008-01
• Primary Completion: 2011-06
• Study Completion: 2014-01
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

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 Lungwena Health Centre or Malindi Hospital catchment area

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Exclusion Criteria

• Existing or imminent severe stunting (HAZ < -2.8)
• Weight for length (WFH) < 80% of the reference median or presence of oedema
• 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
LP	Maize-soy flour	Likuni Phala. Counseling + Vitamin A as for ST-DI + 1 kg fortified maize / soy flour 2-weekly (71 g / day) between 6 and 18 months of age.
FSm	Milk-containing fortified spread	Fortified Spread (milk). Counseling + Vitamin A as for ST-DI + 750 g of fortified spread (FSm) 2-weekly (54 g / day) between 6 and 18 months of age.
FSs	Soy-containing fortified spread	Counselling + Vitamin A as for ST-DI + 750 g of modified fortified spread (FSs) 2-weekly (54 g / day) between 6 and 18 months of age.

Primary Outcome Measures

Name	Time	Method
Incidence of severe stunting (Length-for-age Z score < -3)	1 year after enrolment
Incidence of serious and non-serious adverse events	1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of moderate or severe stunting (Length-for-age Z-score < -2)	1 year
Length gain (cm)	1 year
Weight gain (g)	1 year
Change in anthropometric indices (Weight-for-age Z-score, Weight-for-length Z-score, Length-for-age Z-score), mid-upper arm circumference and head circumference	1 year
Incidence of moderate or severe underweight or wasting (Weight-for-age Z-score or Weight-for-length Z-score <-2 / -3 SD units)	1 year
Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration	18 months of age
Motor, social, and language development (timing of acquisition of defined skills)	1 year
Incidence of febrile illnesses and laboratory diagnosed malaria	1 year
Morbidity for respiratory infections, diarrhea, and other illnesses	1 year

Trial Locations

Locations (1)

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