ClinicalTrials.gg
CompletedNCT00819858Updated Oct 16, 2013

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

An interventional study of RUTF (Plumpynut®) in Weight Loss, Weight Gain and Convalescence, sponsored by Medecins Sans Frontieres, Netherlands. Completed at 1 site in Congo. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2013-10-16.

Primary conditionWeight GainRegistry: Weight LossReclassifiedWhy we changed it
Registry
Weight Loss — the first condition term the registry derived for this study.
ClinicalTrials.gg
Weight Gain
Why
  1. Weight Loss is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Weight Gain.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Medecins Sans Frontieres, Netherlands · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
6 Months to 59 Months
Sex
All
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

  • Weight Loss
  • Weight Gain
  • Convalescence
  • Malaria

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Keywords

  • weight loss
  • weight gain
  • malnutrition
  • convalescence
  • malaria
  • RUTF
  • RUF
  • supplementation
  • nutrition
03

In context

Weight Gain Reclassified

317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.

This study's enrollment of 180 is above the median of 83 across 251 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

Medecins Sans Frontieres, Netherlands is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Compared within Weight Gain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
6 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    RUTF

    RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks

    Dietary Supplement: RUTF (Plumpynut®)

  • No intervention
    control

    no supplement given

Interventions

  • Dietary supplementRUTF (Plumpynut®)

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

    Also known as: RUTF, Ready to use Therapeutic Food, RUF, Lipid based food supplement

06

What researchers measure

Primary outcomes

  1. weight gain

    Time frame: 14 days

Secondary outcomes

  1. weight gain

    Time frame: 28 days

07

Study locations

1 site
  • Central Hospital
    Dubie, Katanga, Congo
08

References and documents

Publications

  • van der Kam S, Swarthout T, Niragira O, Froud A, Sompwe EM, Mills C, Roll S, Tinnemann P, Shanks L. Ready-to-use therapeutic food for catch-up growth in children after an episode of Plasmodium falciparum malaria: an open randomised controlled trial. PLoS One. 2012;7(4):e35006. doi: 10.1371/journal.pone.0035006. Epub 2012 Apr 25. PubMed 22558108 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00819858
Lead sponsor
Medecins Sans Frontieres, Netherlands
Responsible party
Saskia van der Kam (Ir, Medecins Sans Frontieres, Netherlands) — Principal investigator
First posted
Jan 9, 2009
Start date
Jan 2009
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Oct 16, 2013

Study contacts

Saskia van der Kam, Ir
principal investigator · nutrition expert MSF

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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