Effectiveness Trial on Alleviation of Infant Malnutrition With Fortified Spread or Maize-Soy Flour Food Supplements
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00420758|
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : December 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition||Dietary Supplement: Food supplement: fortified spread Dietary Supplement: Food supplement: maize-soy flour||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||299 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||November 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
|No Intervention: Control|
Lipid-based nutrient supplement
Dietary Supplement: Food supplement: fortified spread
Provision of fortified spread
Corn-soy blend supplement
Dietary Supplement: Food supplement: maize-soy flour
Provision of corn-soy blend (maize-soy flour)
- Weight gain during the 12-week follow-up (in grams) [ Time Frame: 12 weeks ]
- Length gain during the 12-week follow-up (in centimetres [ Time Frame: 12 weeks ]
- Change in blood haemoglobin concentration during the study period (g/l) [ Time Frame: 12 weeks ]
- Change in anthropometric indices (WAZ, WHZ and HAZ) [ Time Frame: 12 weeks ]
- Proportion developing moderate or severe wasting during the intervention (WHM<80% of the reference mean) [ Time Frame: 12 weeks ]
- Change in mid-upper arm and head circumference [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420758
|College of Medicine, University of Malawi|
|Mangochi, Mangochi District, Malawi|
|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|