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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-centre, Randomised, Single-blind, Parallel Group Clinical Trial in Rural Malawi, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With a High-energy, Micronutrient Fortified Spread

Conditions
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Malnutrition, Stunting, Developmental Delay

Intervention / Treatment
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* Dietary Supplement: Milk-containing fortified spread
* Dietary Supplement: Soy-containing fortified spread
* Dietary Supplement: Maize-soy flour


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ST-DI<br>Standard treatment - delayed intervention. Counselling on complementary feeding + Vitamin A (200,000 IU) every 6 months until 36 months + 1 kg maize / soy flour 2-weekly (71 g / day) between 18 and 30 months of age. | |
| Experimental: FSm<br>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. | Dietary Supplement: Milk-containing fortified spread<br>* 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.<br>|
| Experimental: FSs<br>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. | Dietary Supplement: Soy-containing fortified spread<br>* Counseling + 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.<br>|
| Experimental: LP<br>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. | Dietary Supplement: Maize-soy flour<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Sub-Saharan Africa, Complementary feeding, Fortified spread, Lipid-based nutrient supplement, Malnutrition, Stunting, Growth, Morbidity, Development, Haemoglobin