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

LCNI-7. A Three-centre Intervention Trial in Rural Malawi, Testing the Effectiveness of Fortified Spread or Maize-Soy Flour Supplementation to Alleviate Moderate Malnutrition Among 6-18 Month Old Children

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Food supplement: fortified spread; Dietary supplement: Food supplement: maize-soy flour

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.

• Study Type: Interventional
• Enrollment (Actual): 299
• Phase: Phase 3

Contacts and Locations

Study Locations

• Malawi
  • Mangochi District
    • Mangochi, Mangochi District, Malawi
      • College of Medicine, University of Malawi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: LNS; Lipid-based nutrient supplement	Dietary supplement: Food supplement: fortified spread; Provision of fortified spread
Experimental: CSB; Corn-soy blend supplement	Dietary supplement: Food supplement: maize-soy flour; Provision of corn-soy blend (maize-soy flour)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight gain during the 12-week follow-up (in grams)	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Length gain during the 12-week follow-up (in centimetres	12 weeks
Change in blood haemoglobin concentration during the study period (g/l)	12 weeks
Change in anthropometric indices (WAZ, WHZ and HAZ)	12 weeks
Proportion developing moderate or severe wasting during the intervention (WHM<80% of the reference mean)	12 weeks
Change in mid-upper arm and head circumference	12 weeks

Collaborators and Investigators

• Sponsor: Tampere University
• Investigators: Study Director: Per Ashorn, MD, PhD, University of Tampere, Medical School, Finland; Principal Investigator: Kenneth Maleta, MBBS, PhD, University of Malawi, College of Medicine, Department of Community Health

Publications and helpful links

Helpful Links

• College of Medicine home page

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: January 10, 2007
• First Submitted That Met QC Criteria: January 10, 2007
• First Posted (Estimate): January 11, 2007

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Treatment; Growth; Infant; Sub-Saharan Africa; Malnutrition; Food supplement; Haemoglobin; Fortified spread
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: AF-109796-b