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

Malnutrition Clinical Trial

— LCNI-5  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524446
• Other study ID #: LTS-2007-02-19
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2007
• Last updated: May 20, 2014
• Start date: January 2008
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: January 2014
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 6 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Developmental Delay
• Growth Disorders
• Malnutrition
• Stunting

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Malawi	College of Medicine, University of Malawi	Mangochi

Sponsors (5)

Lead Sponsor	Collaborator
University of Tampere	Academy of Finland, Foundation for Paediatric Research, Finland, Medical Research Fund of the Tampere University Hospital, Finland, University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe stunting (Length-for-age Z score < -3)		1 year after enrolment	No
Primary	Incidence of serious and non-serious adverse events		1 year	Yes
Secondary	Incidence of moderate or severe stunting (Length-for-age Z-score < -2)		1 year	No
Secondary	Length gain (cm)		1 year	No
Secondary	Weight gain (g)		1 year	No
Secondary	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	No
Secondary	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	No
Secondary	Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration		18 months of age	No
Secondary	Motor, social, and language development (timing of acquisition of defined skills)		1 year	No
Secondary	Incidence of febrile illnesses and laboratory diagnosed malaria		1 year	No
Secondary	Morbidity for respiratory infections, diarrhea, and other illnesses		1 year	No

External Links

•   College of Medicine homepage
•   Home page for University of Tampere Medical School, Department of International Health