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. Identifier: NCT00420758
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : December 4, 2015
Information provided by (Responsible Party):
Per Ashorn, University of Tampere

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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Food supplement: fortified spread Dietary Supplement: Food supplement: maize-soy flour Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
Experimental: LNS
Lipid-based nutrient supplement
Dietary Supplement: Food supplement: fortified spread
Provision of fortified spread

Experimental: CSB
Corn-soy blend supplement
Dietary Supplement: Food supplement: maize-soy flour
Provision of corn-soy blend (maize-soy flour)

Primary Outcome Measures :
  1. Weight gain during the 12-week follow-up (in grams) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Length gain during the 12-week follow-up (in centimetres [ Time Frame: 12 weeks ]
  2. Change in blood haemoglobin concentration during the study period (g/l) [ Time Frame: 12 weeks ]
  3. Change in anthropometric indices (WAZ, WHZ and HAZ) [ Time Frame: 12 weeks ]
  4. Proportion developing moderate or severe wasting during the intervention (WHM<80% of the reference mean) [ Time Frame: 12 weeks ]
  5. Change in mid-upper arm and head circumference [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00420758

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

Additional Information:
Responsible Party: Per Ashorn, PROFESSOR OF PEDIATRICS, University of Tampere Identifier: NCT00420758     History of Changes
Other Study ID Numbers: AF-109796-b
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Keywords provided by Per Ashorn, University of Tampere:
Sub-Saharan Africa
Fortified spread
Food supplement

Additional relevant MeSH terms:
Nutrition Disorders