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Trial record 1 of 1 for:    NCT00131209
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Trial to Test the Growth-Promoting Effect of Fortified Spreads When Used as Complementary Food for Infants

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: NCT00131209
Recruitment Status : Completed
First Posted : August 17, 2005
Last Update Posted : July 8, 2008
Academy of Finland
Foundation for Paediatric Research, Finland
Information provided by:
Tampere University

Brief Summary:
This study tests the hypothesis that infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: fortified spread (RUTF) Dietary Supplement: maize and 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 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 in Mangochi District, southern Malawi. In the present study the investigators will test the efficacy in growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age.

The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 180 6-month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 months. Children in group-one (control group) will receive 75g of maize/soy flour daily. Children in group-two will receive 25g RUTF daily and children in group-three will receive 50g RUTF daily for a period of 12 months. The food supplements will be delivered to the participant's home at weekly intervals.

All children will undergo medical and anthropometric examinations at 4-monthly intervals and disease symptoms monitoring every week. Dietary intake assessments will be conducted at 12 and 15 months of age. A random sample of 36 children will undergo breast milk intake assessments before the start of food supplementation and during food supplementation. A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations and test human immunodeficiency virus [HIV] (at 6 and 18 months).

The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups. Secondary outcomes include length gain, incidence of moderate underweight, stunting and wasting, cognitive and motor development at the end of trial and changes in blood haemoglobin and serum ferritin concentration. The study will also produce descriptive data on morbidity and intake of breast milk and other foods during the intervention.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Lungwena Child Nutrition Intervention Study 3, LCNI-3. A Single-Centre Intervention Trial in Rural Malawi, Testing the Anthropometric and Health Benefits of Provision of Ready to - Use - Therapeutic Food RUTF as a Complementary Food
Study Start Date : October 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Primary Outcome Measures :
  1. Weight gain during the 12-month follow-up (in grams)

Secondary Outcome Measures :
  1. Length gain during the study period (cm)
  2. Cognitive and motor developmental score at the end of trial
  3. Change in blood haemoglobin concentration during the study period (g/l)
  4. Change in serum ferritin concentration during the study period (µg/l)
  5. Mean change in anthropometric indices (weight-for-age z-score [WAZ], weight-for-height z-score [WHZ] and height-for-age z-score [HAZ])
  6. Incidence of undernutrition, stunting and wasting (WAZ, WHZ or HAZ < -2.0)

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Signed informed consent from at least one guardian
  • Ages 5.50 months to 6.49 months
  • Availability during the period of the study
  • Permanent resident of the area

Exclusion Criteria:

  • WHZ < -2.0 z-scores or presence of oedema
  • History of peanut allergy
  • Severe illness warranting hospital referral
  • Concurrent participation of the child 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): NCT00131209

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College of Medicine, University of Malawi
Mangochi, Mangochi District, Malawi
Sponsors and Collaborators
Tampere University
Academy of Finland
Foundation for Paediatric Research, Finland
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Study Director: Per Ashorn, MD, PhD University of Tampere, Medical School
Principal Investigator: Kenneth Maleta, MBBS, PhD University of Malawi College of Medicine
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Per Ashorn, University of Tampere Medical School, Finland Identifier: NCT00131209    
Other Study ID Numbers: SA-1200720-3
First Posted: August 17, 2005    Key Record Dates
Last Update Posted: July 8, 2008
Last Verified: July 2008
Keywords provided by Tampere University:
Sub-Saharan Africa
Complementary feeding
Fortified spread
Additional relevant MeSH terms:
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Nutrition Disorders