Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants (LCNI-5)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malnutrition Stunting Developmental Delay |
Dietary Supplement: Milk-containing fortified spread Dietary Supplement: Soy-containing fortified spread Dietary Supplement: Maize-soy flour |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
- Incidence of severe stunting (Length-for-age Z score < -3) [ Time Frame: 1 year after enrolment ] [ Designated as safety issue: No ]
- Incidence of serious and non-serious adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Incidence of moderate or severe stunting (Length-for-age Z-score < -2) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Length gain (cm) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Weight gain (g) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
- Motor, social, and language development (timing of acquisition of defined skills) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Incidence of febrile illnesses and laboratory diagnosed malaria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Morbidity for respiratory infections, diarrhea, and other illnesses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 840 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2014 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
|
|
Experimental: FSm
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.
|
|
Experimental: FSs
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.
|
|
Experimental: LP
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.
|
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.
Eligibility| Ages Eligible for Study: | 6 Months to 6 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Malawi | |
| College of Medicine, University of Malawi | |
| Mangochi, 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 |
More Information
Additional Information:
No publications provided by University of Tampere
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Per Ashorn, Professor of International Health, University of Tampere |
| ClinicalTrials.gov Identifier: | NCT00524446 History of Changes |
| Other Study ID Numbers: | LTS-2007-02-19 |
| Study First Received: | August 31, 2007 |
| Last Updated: | June 17, 2012 |
| Health Authority: | Malawi: College of Medicine Research and Ethics Committee |
Keywords provided by University of Tampere:
|
Infant Sub-Saharan Africa Complementary feeding Fortified spread Lipid-based nutrient supplement Malnutrition |
Stunting Growth Morbidity Development Haemoglobin |
Additional relevant MeSH terms:
|
Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on June 18, 2013