Clinical trial NCT00420758: Effectiveness Trial on Alleviation of Infant Malnutrition With Fortified Spread or Maize-Soy Flour Food Supplements
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malnutrition
Keywords: Infant
Malnutrition
Sub-Saharan Africa
Treatment
Growth
Haemoglobin
Fortified spread
Food supplement
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 299
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Weight gain during the 12-week follow-up (in grams)
timeFrame: 12 weeks
Secondary outcomes:
measure: Length gain during the 12-week follow-up (in centimetres
timeFrame: 12 weeks
measure: Change in blood haemoglobin concentration during the study period (g/l)
timeFrame: 12 weeks
measure: Change in anthropometric indices (WAZ, WHZ and HAZ)
timeFrame: 12 weeks
measure: Proportion developing moderate or severe wasting during the intervention (WHM<80% of the reference mean)
timeFrame: 12 weeks
measure: Change in mid-upper arm and head circumference
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mangochi
country: Malawi
facility: College of Medicine, University of Malawi
state: Mangochi District
Study officials:
affiliation: University of Tampere, Medical School, Finland
name: Per Ashorn, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Malawi, College of Medicine, Department of Community Health
name: Kenneth Maleta, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: