MalnutritionNCT01154803
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
A study testing Ready to Use Therapeutic Food (RUTF) and Micronutrient Powder (MNP) in people with Malnutrition and Malaria, run by Medecins Sans Frontieres, Netherlands at 1 site in Nigeria.
Trial summary
The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malnutrition, Malaria, Lower Respiratory Tract Infection
- What is being tested?
- Ready to Use Therapeutic Food (RUTF) and Micronutrient Powder (MNP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,213 participants
- Where
- 1 siteNigeria
- Study dates
- Feb 2012to Feb 2013
- 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
- 6 to 59 months of age
- Not malnourished or moderately acutely malnourished children
- Diagnosis of malaria and/or diarrhoea and/or LRTI
- Intending to remain in area for the duration of the 6 month follow-up
- Living within approximately 60 minutes walking distance from the clinic
- Informed consent from a guardian*
Who cannot join
- Child is exclusively breastfeeding
- Child is severely malnourished
- Presence of 'General Danger Signs'
- Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)
- Needing hospitalisation for any reason
- Known history of allergy to the nutritional supplementation
- Having a sibling enrolled in the study*
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Goronyo health clinic outpatient department
Goronyo, Sokoto State
About this study
Official title: Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled Trial in Nigeria
The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.
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.
A complete high quality food will be tested, but also micronutrients alone as there is no information on what children with an infection exactly need as a supplement.
Children aged 6-59 months presenting with diarrhoea, malaria or lower respiratory tract infection (LRTI) are provided for 2 weeks with
- RUTF supplement (Plumpynut®) of 500 kcal/day
- Multi-micronutrient powder (MNP)
- Placebo to MNP
The followup period is 6 months. Anthropometric indicators and morbidity are assessed monthly. Participants are invited to attend the study clinic if any signs of disease are noticed.
- Conditions
- Malnutrition, Malaria, Lower Respiratory Tract Infection, Diarrhoea
- Being tested
- Ready to Use Therapeutic Food (RUTF), Micronutrient Powder (MNP)
- Keywords
- Supplementation, RUTF, Micronutrients, Plumpynut, Mixme, sprinkles, convalescence, weight, morbidity
- Medical subject headings
- Malnutrition, Malaria, Diarrhea, Convalescence, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready to Use Therapeutic Food (RUTF)Dietary supplement
Also called RUTF: Nutriset
1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia)
Micronutrient Powder (MNP)Dietary supplement
Also called MNP: DSM
2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)
| Study group | Role | What they receive |
|---|---|---|
| Ready to Use Therapeutic Food (RUTF) | Experimental | 500 kcal /day for 2 weeks Receives: Dietary Supplement: Ready to Use Therapeutic Food (RUTF) |
| Micronutrient Powder (MNP) | Experimental | 2 x 1 g sachets micronutrients /day for 2 weeks Receives: Dietary Supplement: Micronutrient Powder (MNP) |
| no supplement | No intervention | no supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
"negative nutritional outcome" of a child
The incidence of a negative nutritional outcome will be defined in two different ways according to the baseline nutritional status.
- for children with no malnourishment at time of entry into study, "negative nutritional outcome" is defined as progression to moderate or severe malnourishment ii) for children with moderate malnourishment at time of entry into study, "negative nutritional outcome" is defined as loss of ³10% of baseline weight or progression to severe malnourishment, whichever is reached first.
Measured: 6 months follow-up
Secondary outcomes (1)
Number of new events of a study disease
study disease: malaria, diarrhoea, and LRTI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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 MalnutritionStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,213 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 Kam van der, Ir, Principal investigator, Medecins Sans Frontieres Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154803
- Sponsor's protocol ID
- MSF-nutcon02
- Status last verified
- Oct 2013
- First submitted
- 30 Jun 2010
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Kam S, Salse-Ubach N, Roll S, Swarthout T, Gayton-Toyoshima S, Jiya NM, Matsumoto A, Shanks L. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Nigeria. PLoS Med. 2016 Feb 9;13(2):e1001952. doi: 10.1371/journal.pmed.1001952. eCollection 2016 Feb.
PubMed 26859559
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
- Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled Trial in Nigeria
- ClinicalTrials.gov ID
- NCT01154803
- Acronym / sponsor ID
- MSF-nutcon02
- Conditions
- Malnutrition, Malaria, Lower Respiratory Tract Infection, Diarrhoea
- Keywords
- Supplementation, RUTF, Micronutrients, Plumpynut, Mixme, sprinkles, convalescence, weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,213 participants (actual)
- Lead sponsor
- Medecins Sans Frontieres, NetherlandsUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Jul 2010 (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 purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.
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.
A complete high quality food will be tested, but also micronutrients alone as there is no information on what children with an infection exactly need as a supplement.
Children aged 6-59 months presenting with diarrhoea, malaria or lower respiratory tract infection (LRTI) are provided for 2 weeks with
- RUTF supplement (Plumpynut®) of 500 kcal/day
- Multi-micronutrient powder (MNP)
- Placebo to MNP
The followup period is 6 months. Anthropometric indicators and morbidity are assessed monthly. Participants are invited to attend the study clinic if any signs of disease are noticed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ready to Use Therapeutic Food (RUTF) | Experimental | Dietary Supplement: Ready to Use Therapeutic Food (RUTF)500 kcal /day for 2 weeks |
| Micronutrient Powder (MNP) | Experimental | Dietary Supplement: Micronutrient Powder (MNP)2 x 1 g sachets micronutrients /day for 2 weeks |
| no supplement | No intervention | –no supplementation |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 6 to 59 months of age
- Not malnourished or moderately acutely malnourished children
- Diagnosis of malaria and/or diarrhoea and/or LRTI
- Intending to remain in area for the duration of the 6 month follow-up
- Living within approximately 60 minutes walking distance from the clinic
Key exclusion criteria (7 listed)
- Child is exclusively breastfeeding
- Child is severely malnourished
- Presence of 'General Danger Signs'
- Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)
- Needing hospitalisation for any reason
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 |
|---|---|---|
| Ready to Use Therapeutic Food (RUTF)Also: RUTF: Nutriset1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia) | Dietary supplement | Ready to Use Therapeutic Food (RUTF) |
| Micronutrient Powder (MNP)Also: MNP: DSM2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia) | Dietary supplement | Micronutrient Powder (MNP) |
Primary outcome
"negative nutritional outcome" of a child
Time frame: 6 months follow-up
The incidence of a negative nutritional outcome will be defined in two different ways according to the baseline nutritional status. i) for children with no malnourishment at time of entry into study, "negative nutritional outcome" is defined as progression to moderate or severe malnourishment ii) for children with moderate malnourishment at time of entry into study, "negative nutritional outcome" is defined as loss of ³10% of baseline weight or progression to severe malnourishment, whichever is reached first.
1 secondary outcome
Number of new events of a study disease
Time frame: 6 months
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 26859559van der Kam S, Salse-Ubach N, Roll S, Swarthout T, Gayton-Toyoshima S, Jiya NM, Matsumoto A, Shanks L. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Nigeria. PLoS Med. 2016 Feb 9;13(2):e1001952. doi: 10.1371/journal.pmed.1001952. eCollection 2016 Feb.
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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 Kam van der, Ir principal investigator
Medecins Sans Frontieres Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready to Use Therapeutic Food (RUTF) and Micronutrient Powder (MNP) in people with Malnutrition and Malaria, run by Medecins Sans Frontieres, Netherlands at 1 site in Nigeria.
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 6 inclusion and 7 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 Nigeria. 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?
"negative nutritional outcome" of a child (time frame: 6 months follow-up). 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 NCT01154803, 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.