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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Malnutrition
- Sponsor
- Tampere University
- Enrollment
- 840
- Locations
- 1
- Primary Endpoint
- Incidence of severe stunting (Length-for-age Z score < -3)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Per Ashorn
Professor of International Health
Tampere University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of severe stunting (Length-for-age Z score < -3)
Time Frame: 1 year after enrolment
Incidence of serious and non-serious adverse events
Time Frame: 1 year
Secondary Outcomes
- Incidence of febrile illnesses and laboratory diagnosed malaria(1 year)
- Morbidity for respiratory infections, diarrhea, and other illnesses(1 year)
- 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)