Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants (LCNI-5)
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|ClinicalTrials.gov Identifier: NCT00524446|
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : May 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition Stunting Developmental Delay||Dietary Supplement: Milk-containing fortified spread Dietary Supplement: Soy-containing fortified spread Dietary Supplement: Maize-soy flour||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||840 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||January 2014|
No Intervention: ST-DI
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.
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
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.
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
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.
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
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.
- 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 ]
- Incidence of moderate or severe stunting (Length-for-age Z-score < -2) [ Time Frame: 1 year ]
- Length gain (cm) [ Time Frame: 1 year ]
- Weight gain (g) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 1 year ]
- Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration [ Time Frame: 18 months of age ]
- Motor, social, and language development (timing of acquisition of defined skills) [ Time Frame: 1 year ]
- Incidence of febrile illnesses and laboratory diagnosed malaria [ Time Frame: 1 year ]
- Morbidity for respiratory infections, diarrhea, and other illnesses [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524446
|College of Medicine, University of Malawi|
|Study Director:||Per Ashorn, MD, PhD||University of Tampere Medical School, Finland|
|Principal Investigator:||Kenneth Maleta, MBBS, PhD||College of Medicine, University of Malawi|