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Completed

NCT Number: NCT00998517

Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition

The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malawi College of Medicine

Blantyre, 03, Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • WHZ <-2 but >-3 without bilateral pedal edema
  • Reside within 7 kilometers of study site.

Exclusion criteria

  • Not permanent resident in vicinity of study site.
  • Severe chronic illness such as cerebral palsy.
  • History of peanut allergy or anaphylaxis resulting from any food.
  • Receiving other supplementary food or participating in other research.

Treatment and study plan

Soy/peanut fortified spread

Dietary Supplement

75kcal/kg/day

Milk fortified corn/soy blend

Dietary Supplement

75 kcal/kg/day

Supplementary Plumpy®

Dietary Supplement

75 kcal/kg/day

Primary outcomes

  1. Number of Participants With Nutritional Recovery

    Time frame: 12 weeks or upon completion of recovery

    Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length.

    WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/

  2. Number of Patients With Absence of Bilateral Pedal Pitting Edema

    Time frame: 12 weeks or recovery

Secondary outcomes

  1. Rate of Weight Gain

    Time frame: 4 weeks

    This rate will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks

  2. Number of Patients With Adverse Outcomes

    Time frame: 12 months

    This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.

  3. Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment

    Time frame: 2 weeks

  4. Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)

    Time frame: 12 months

    Children who were successfully treated for MAM in the primary portion of the study were followed prospectively with scheduled follow-up visits for 12 months to evaluate whether they remained well-nourished, defined as mid-upper arm circumference (MUAC) >= 12.5 cm or weight-for-height Z-score >= -2 throughout the duration of follow-up.

  5. Rates of Gain in Mid-upper Arm Circumference, and Length

    Time frame: 4 weeks

    These rates will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Comparison of a Novel Fortified Blended Flour to Ready-to-use Supplemental Foods for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomized, Investigator-blinded, Clinical Effectiveness Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2009
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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