Trial to Alleviate Malnutrition With Fortified Spread Given as a Food Supplement to Underweight Infants

This study has been completed.
Sponsor:
Collaborators:
Academy of Finland
Foundation for Paediatric Research, Finland
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00131222
First received: August 16, 2005
Last updated: April 18, 2007
Last verified: April 2007

August 16, 2005
April 18, 2007
February 2005
Not Provided
Weight gain during the 12-week follow-up (in grams)
Same as current
Complete list of historical versions of study NCT00131222 on ClinicalTrials.gov Archive Site
  • Length gain during the study period (mm)
  • Tibial length gain during the study period (mm)
  • Change in blood haemoglobin concentration during the study period (g/l)
  • Change in serum ferritin concentration during the study period (µg/l)
  • Mean change in anthropometric indices (weight-for-age z-score [WAZ], weight-for-height z-score [WHZ] and height-for-age z-score [HAZ])
  • Length gain during the study period (mm)
  • Tibial length gain during the study period (mm)
  • Change in blood haemoglobin concentration during the study period (g/l)
  • Change in serum ferritin concentration during the study period (µg/l)
  • Mean change in anthropometric indices (WAZ, WHZ and HAZ)
Not Provided
Not Provided
 
Trial to Alleviate Malnutrition With Fortified Spread Given as a Food Supplement to Underweight Infants
Lungwena Child Nutrition Intervention Study-4, LCNI-4. A Single-Centre Intervention Trial in Rural Malawi, Testing the Potency of RUTF Supplementation to Alleviate Moderate Malnutrition Among 6-17 Month Old Infants

This study tests the hypothesis that underweight 6-17-month old infants receiving fortified spread as a food supplement for 12 weeks grow better during the supplementation than infants who are provided with maize-soy flour 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 nutrient –dense spread, ready-to use- therapeutic food (RUTF), 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 infants (defined as WAZ <-2) between 6 and 18 months of age.

The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 176 6-14 -month old infants will be enrolled and randomised to two groups receiving different daily food supplements for 12 weeks. Children in group one (control group) will receive 72g of fortified maize/soy flour and children in group 2 will receive 50g RUTF daily. The food supplements will be delivered to the participant’s home at 3-weekly intervals.

All children will undergo medical and anthropometric examinations at 6-weekly intervals and disease symptoms monitoring every week. Dietary intake assessments will be conducted at 3 and 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 and serum ferritin concentrations. At enrolment, children's HIV status will be screened with antibody-ELISA and confirmed with HIV PCR.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Malnutrition
  • Procedure: Food supplement: fortified spread
  • Procedure: Food supplement: maize and soy flour
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
September 2005
Not Provided

Inclusion Criteria:

  • Signed informed consent from at least one guardian
  • Ages 6.00 months to 14.99 months
  • Weight-for-age < -2 z-scores
  • Availability during the period of the study
  • Permanent resident of the area

Exclusion Criteria:

  • WHZ < -3 z-scores or presence of oedema
  • History of peanut allergy
  • 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
 
NCT00131222
SA-1200720-4
Yes
Not Provided
University of Tampere
  • Academy of Finland
  • Foundation for Paediatric Research, Finland
Study Director: Per Ashorn, MD, PhD University of Tampere, Medical School
Principal Investigator: Kenneth M Maleta, MBBS, PhD University of Malawi College of Medicine
University of Tampere
April 2007

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