Efficacy Trial on Alleviation of Infant Malnutrition With Fortified Spread or Maize-soy Flour Food Supplements

This study has been completed.
Sponsor:
Collaborator:
University of Malawi College of Medicine
Information provided by (Responsible Party):
Per Ashorn, University of Tampere
ClinicalTrials.gov Identifier:
NCT00420368
First received: January 10, 2007
Last updated: June 17, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Malnutrition
Dietary Supplement: No food supplement
Dietary Supplement: Food supplement: fortified spread
Dietary Supplement: Food supplement: maize-soy flour
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: LCNI-6. A Single-centre Intervention Trial in Rural Malawi, Testing the Efficacy of Fortified Spread or Maize-soy Flour Supplementation to Alleviate Moderate Malnutrition Among 6-18 Month Old Children

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 12-week follow-up (in centimetres)
  • Change in blood haemoglobin concentration during the study period (g/l)
  • Change in serum ferritin concentration during the study period (µg/l)
  • Change in anthropometric indices (WAZ, WHZ and HAZ)
  • Proportion developing moderate or severe wasting during the intervention (WHM<80% of the reference median)
  • Change in mid-upper arm and head circumference

Estimated Enrollment: 189
Study Start Date: February 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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 189 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 300 g FS weekly (43 g / day) and children in group 3 will received 500 g of fortified maize/soy flour weekly (71 g / day). The food supplements will be delivered to the participant's home at 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 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.

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 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
  • 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
  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: NCT00420368

Locations
Malawi
College of Medicine, University of Malawi
Mangochi, Mangochi District, Malawi
Sponsors and Collaborators
University of Tampere
University of Malawi College of Medicine
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
  More Information

Additional Information:
Publications:
Responsible Party: Per Ashorn, Professor of International Health, University of Tampere
ClinicalTrials.gov Identifier: NCT00420368     History of Changes
Other Study ID Numbers: AF-109796-a
Study First Received: January 10, 2007
Last Updated: June 17, 2012
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
Infant Nutrition Disorders
Nutrition Disorders

ClinicalTrials.gov processed this record on July 24, 2014