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: May 19, 2014
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Malnutrition
Procedure: Food supplement: fortified spread
Procedure: Food supplement: maize and soy flour
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Weight gain during the 12-week follow-up (in grams)

Secondary Outcome Measures:
  • 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])

Estimated Enrollment: 176
Study Start Date: February 2005
Study Completion Date: September 2005
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 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.

  Eligibility

Ages Eligible for Study:   6 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131222

Locations
Malawi
College of Medicine, University of Malawi
Mangochi, Mangochi District, Malawi
Sponsors and Collaborators
University of Tampere
Academy of Finland
Foundation for Paediatric Research, Finland
Investigators
Study Director: Per Ashorn, MD, PhD University of Tampere, Medical School
Principal Investigator: Kenneth M Maleta, MBBS, PhD University of Malawi College of Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00131222     History of Changes
Other Study ID Numbers: SA-1200720-4
Study First Received: August 16, 2005
Last Updated: May 19, 2014
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Keywords provided by University of Tampere:
Infant
Malnutrition
Sub-Saharan Africa
Treatment
Growth
Haemoglobin
Fortified spread
Food supplement

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 21, 2014