Weight LossNCT00819858
Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight
A study testing RUTF (Plumpynut®) in people with Weight Loss and Weight Gain, run by Medecins Sans Frontieres, Netherlands at 1 site in Republic of the Congo.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Weight Loss, Weight Gain, Convalescence
- What is being tested?
- RUTF (Plumpynut®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- Jan 2009to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria
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).
- Conditions
- Weight Loss, Weight Gain, Convalescence, Malaria
- Being tested
- RUTF (Plumpynut®)
- Keywords
- weight loss, weight gain, malnutrition, convalescence, malaria, RUTF, RUF, supplementation, nutrition
- Medical subject headings
- Weight Loss, Weight Gain, Convalescence, Malaria, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUTF (Plumpynut®)Dietary supplement
Also called RUTF, Ready to use Therapeutic Food, RUF, Lipid based food supplement
Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement
| Study group | Role | What they receive |
|---|---|---|
| RUTF | Experimental | RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks Receives: Dietary Supplement: RUTF (Plumpynut®) |
| control | No intervention | no supplement given |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
Measured: 14 days
Secondary outcomes (1)
weight gain
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medecins Sans Frontieres, Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saskia van der Kam, Medecins Sans Frontieres, Netherlands
- Investigators
- Saskia van der Kam, Ir, Principal investigator, nutrition expert MSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819858
- Sponsor's protocol ID
- MSF-nutcon01
- Status last verified
- Oct 2013
- First submitted
- 8 Jan 2009
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria
- ClinicalTrials.gov ID
- NCT00819858
- Acronym / sponsor ID
- MSF-nutcon01
- Conditions
- Weight Loss, Weight Gain, Convalescence, Malaria
- Keywords
- weight loss, weight gain, malnutrition, convalescence, malaria, RUTF, RUF, supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medecins Sans Frontieres, NetherlandsUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUTF | Experimental | Dietary Supplement: RUTF (Plumpynut®)RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks |
| control | No intervention | –no supplement given |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RUTF (Plumpynut®)Also: RUTF, Ready to use Therapeutic Food, RUF, Lipid based food supplementIntervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement | Dietary supplement | RUTF |
Primary outcome
weight gain
Time frame: 14 days
1 secondary outcome
weight gain
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Derived from this study: PubMed 22558108van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saskia van der Kam, Ir principal investigator
nutrition expert MSF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RUTF (Plumpynut®) in people with Weight Loss and Weight Gain, run by Medecins Sans Frontieres, Netherlands at 1 site in Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00819858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.