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Trial record 19 of 110 for:    test | ( Map: Malawi )

Trial to Alleviate Malnutrition With Fortified Spread Given as a Food Supplement to Underweight Infants

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ClinicalTrials.gov Identifier: NCT00131222
Recruitment Status : Completed
First Posted : August 17, 2005
Last Update Posted : May 20, 2014
Sponsor:
Collaborators:
Academy of Finland
Foundation for Paediatric Research, Finland
Information provided by:
Tampere University

Tracking Information
First Submitted Date  ICMJE August 16, 2005
First Posted Date  ICMJE August 17, 2005
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2005)
Weight gain during the 12-week follow-up (in grams)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00131222 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2005)
  • Length gain during the study period (mm)
  • Tibial length gain during the study period (mm)
  • Change in blood haemoglobin concentration during the study period (g/l)
  • Change in serum ferritin concentration during the study period (µg/l)
  • Mean change in anthropometric indices (weight-for-age z-score [WAZ], weight-for-height z-score [WHZ] and height-for-age z-score [HAZ])
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2005)
  • Length gain during the study period (mm)
  • Tibial length gain during the study period (mm)
  • Change in blood haemoglobin concentration during the study period (g/l)
  • Change in serum ferritin concentration during the study period (µg/l)
  • Mean change in anthropometric indices (WAZ, WHZ and HAZ)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Alleviate Malnutrition With Fortified Spread Given as a Food Supplement to Underweight Infants
Official Title  ICMJE Lungwena Child Nutrition Intervention Study-4, LCNI-4. A Single-centre Intervention Trial in Rural Malawi, Testing the Potency of RUTF Supplementation to Alleviate Moderate Malnutrition Among 6-17 Month Old Infants
Brief Summary This study tests the hypothesis that underweight 6-17-month old infants receiving fortified spread as a food supplement for 12 weeks grow better during the supplementation than infants who are provided with maize-soy flour 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 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 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 infants (defined as WAZ <-2) between 6 and 18 months of age.

The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 176 6-14 -month old infants will be enrolled and randomised to two groups receiving different daily food supplements for 12 weeks. Children in group one (control group) will receive 72g of fortified maize/soy flour and children in group 2 will receive 50g RUTF daily. The food supplements will be delivered to the participant's home at 3-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 3 and 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. At enrolment, children's HIV status will be screened with antibody-ELISA and confirmed with HIV PCR.

The impact of the dietary interventions will be primarily assessed by comparing weight gain in the two intervention groups. Secondary outcomes include length gain, increase in tibial length 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Malnutrition
Intervention  ICMJE
  • Procedure: Food supplement: fortified spread
  • Procedure: Food supplement: maize and soy flour
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 16, 2005)
176
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent from at least one guardian
  • Ages 6.00 months to 14.99 months
  • Weight-for-age < -2 z-scores
  • Availability during the period of the study
  • Permanent resident of the area

Exclusion Criteria:

  • WHZ < -3 z-scores or presence of oedema
  • History of peanut allergy
  • Severe illness warranting hospital referral
  • Concurrent participation in another clinical trial with intervention to the child
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 15 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00131222
Other Study ID Numbers  ICMJE SA-1200720-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Tampere University
Collaborators  ICMJE
  • Academy of Finland
  • Foundation for Paediatric Research, Finland
Investigators  ICMJE
Study Director: Per Ashorn, MD, PhD University of Tampere, Medical School
Principal Investigator: Kenneth M Maleta, MBBS, PhD University of Malawi College of Medicine
PRS Account Tampere University
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP