Effectiveness Trial on Alleviation of Infant Malnutrition With Fortified Spread or Maize-Soy Flour Food Supplements

NCT ID: NCT00420758

Last Updated: 2015-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-05-31

Brief Summary

This study tests the hypothesis that moderately underweight but not severely wasted 6-17-month old infants receiving fortified spread or maize-spy flour as a food supplement for 12 weeks grow better during the supplementation than infants who do not get any food supplement.

Detailed Description

Childhood undernutrition is very common in rural Malawi, like in many other countries in Sub-Saharan Africa. Usually, undernutrition develops between 6 and 24 months of age. By two years of age, 30-50% of all children in rural Malawi are undernourished, predisposing them to subsequent morbidity, developmental delay and mortality. Urgent interventions are needed but the magnitude of the problem precludes a hospital-based management strategy. Therefore, emphasis must be on prevention and early home-based rehabilitation of children with mild-to-moderate malnutrition. However, the options for community based approaches are not as developed as those for institutional management of undernutrition.

The present study tests a recently developed micronutrient fortified spread, FS, which offers a potential solution to home based nutrition rehabilitation. The concept has previously been shown to work not only in therapeutic feeding of undernourished children in nutrition rehabilitation units in Malawi but also home based supplementation of undernourished children aged 42 to 60 months in Mangochi District, southern Malawi. In the present study the investigators will test the efficacy in growth promotion of this product when provided as a supplementary food to moderately underweight, but not wasted, infants (defined as WAZ <-2, WHM=>80%) between 6 and 18 months of age.

The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 291 6-15 -month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 weeks. Children in group one (control group) will not receive any supplementation, children in group two will receive 1200 g FS 4-weekly (43 g / day) and children in group 3 will received 2000 g of fortified maize/soy flour weekly (71 g / day). Participant´s guardians will collect the food supplements from a local health centre at 4-weekly intervals.

All children will undergo medical and anthropometric examinations at the beginning and end of the 12-week follow-up period. Dietary intake assessments will be conducted at 9 weeks after the onset of supplementation. A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin concentration.

The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups. Secondary outcomes include length gain and changes in blood haemoglobin concentration. The study will also produce descriptive data on intake of foods during the intervention.

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

LNS

Lipid-based nutrient supplement

Group Type: EXPERIMENTAL

Food supplement: fortified spread

Intervention Type: DIETARY_SUPPLEMENT

Provision of fortified spread

CSB

Corn-soy blend supplement

Group Type: EXPERIMENTAL

Food supplement: maize-soy flour

Intervention Type: DIETARY_SUPPLEMENT

Provision of corn-soy blend (maize-soy flour)

Interventions

Food supplement: fortified spread

Provision of fortified spread

Intervention Type: DIETARY_SUPPLEMENT

Food supplement: maize-soy flour

Provision of corn-soy blend (maize-soy flour)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• signed informed consent from at least one guardian
• age 6.00 months to 14.99 months
• weight-for-age <-2.0 Z scores
• availability during the period of the study
• permanent resident Lungwena Health Centre catchment area

Exclusion Criteria

• moderate or severe wasting (WHM<80% of the reference median)
• history of peanut allergy
• history of any serious allergic reaction to any substance, requiring emergency medical care
• history of anaphylaxis
• severe illness warranting hospital referral
• concurrent participation in another clinical trial with intervention to the child

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University

OTHER

Sponsor Role: lead

Responsible Party

Per Ashorn

PROFESSOR OF PEDIATRICS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Per Ashorn, MD, PhD

Role: STUDY_DIRECTOR

University of Tampere, Medical School, Finland

Kenneth Maleta, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malawi, College of Medicine, Department of Community Health

Locations

College of Medicine, University of Malawi

Mangochi, Mangochi District, Malawi

Countries

Malawi

Related Links

http://www.medcol.mw/

College of Medicine home page

Other Identifiers

AF-109796-b

Identifier Type: -

Identifier Source: org_study_id