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Completed

NCT Number: NCT00819858

Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight

The primary objective of this study is to determine to what extent provision with RUTF will promote catch up growth in children following an acute uncomplicated episode of P. falciparum malaria.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Convalescence Disease Attributes Infections Malaria Malnutrition Mosquito-Borne Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protozoan Infections Signs and Symptoms Vector Borne Diseases Weight Gain

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Hospital

Dubie, Katanga, Republic of the Congo

About this study

Anorexia due to infection might lead to weight loss. In many settings total recovery is problematic what might result in a permanent lower weight. A short period high quality food supplementation could improve weight gain after an infection.

Children aged 6-59 months presenting with malaria caused by P. falciparum who are provided with a RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks will show significantly better catch up growth compared to a similar patient group not provided with RUTF (at 2 weeks and 4 weeks post-intervention).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 6 to 59 months, and
  • Positive rapid diagnostic test (Paracheck®) and
  • Thick smear showing infection with P. falciparum and
  • Informed consent from parents or guardian aged at least 18 years.

Exclusion criteria

  • Children who are exclusively breast fed or
  • Children who are severely malnourished (MUAC <110 mm and/or bilateral oedema, or WHO weight-for-Height criteria <3 Z-scores) or
  • Presence of general danger signs or signs of severe malaria as defined by the WHO criteria, or
  • Known history of allergy to malaria drugs, or
  • Having a sibling enrolled in the study.

Treatment and study plan

RUTF (Plumpynut®)

Dietary Supplement

Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement

Other names: RUTF, Ready to use Therapeutic Food, RUF, Lipid based food supplement

Primary outcomes

  1. weight gain

    Time frame: 14 days

Secondary outcomes

  1. weight gain

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Medecins Sans Frontieres, Netherlands

Other

Registry information

Official study title

The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 9, 2009
Registry last updated
Oct 16, 2013

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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