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

This study has been completed.
Sponsor:
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00420758
First received: January 10, 2007
Last updated: July 7, 2008
Last verified: July 2008

January 10, 2007
July 7, 2008
November 2007
May 2008   (final data collection date for primary outcome measure)
Weight gain during the 12-week follow-up (in grams)
Same as current
Complete list of historical versions of study NCT00420758 on ClinicalTrials.gov Archive Site
  • Length gain during the 12-week follow-up (in centimetres
  • Change in blood haemoglobin concentration during the study period (g/l)
  • Change in anthropometric indices (WAZ, WHZ and HAZ)
  • Proportion developing moderate or severe wasting during the intervention (WHM<80% of the reference mean)
  • Change in mid-upper arm and head circumference
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Malnutrition
  • Dietary Supplement: Food supplement: fortified spread
  • Dietary Supplement: Food supplement: maize-soy flour
  • No Intervention: 1
  • Experimental: 2
    Intervention: Dietary Supplement: Food supplement: fortified spread
  • Experimental: 3
    Intervention: Dietary Supplement: Food supplement: maize-soy flour
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
299
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
6 Months to 15 Months
No
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT00420758
AF-109796-b
Yes
Per Ashorn, University of Tampere Medical School, Finland
University of Tampere
Not Provided
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
University of Tampere
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP