Child MalnutritionMSF-nutcon03NCT01497236
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda
A study testing Dietary Supplement: Nutrition supplement with RUTF or MNP in people with Child Malnutrition and Infant Morbidity, run by Medecins Sans Frontieres, Spain at 1 site in Uganda.
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 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Malnutrition, Infant Morbidity
- What is being tested?
- Dietary Supplement: Nutrition supplement with RUTF or MNP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,202 participants
- Where
- 1 siteUganda
- Study dates
- Mar 2011to Oct 2012
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 to 59 months of age
- Not malnourished
- 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.
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 Kaabong, Karamoja, Uganda
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
similar to MSF-nutcon 03 : NCT01154803
- Conditions
- Child Malnutrition, Infant Morbidity
- Being tested
- Dietary Supplement: Nutrition supplement with RUTF or MNP
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Nutrition supplement with RUTF or MNPDietary supplement
Also called Other Names:, RUTF: Nutriset, MNP: MixMe, DSM, Placebo: DSM
14 days nutritional supplementation with either
- a fortified high quality food(RUTF), 1 sachet/day, 500 kcal and multi micronutrients
- a multi micronutrient powder (MNP), 2 sachets per day, no calories, twice recommended daily intake
- a placebo (to MNP), 2 sachets per day , no calories, no micronutrients, containing micronutrient carrier
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Ready to Use Terapeutic Food (RUTF) | Experimental | Not described Receives: Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP |
| Multi Micronutrient Powder (MNP) | Experimental | Not described Receives: Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP |
| no supplement | No intervention | Not described |
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 posted22 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2012
- Study completionOct 2012
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 Child 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
- 2,202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medecins Sans Frontieres, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuria Salse, Medecins Sans Frontieres, Spain
- Investigators
- Nuria Salse, Principal investigator, MSF Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497236
- Sponsor's protocol ID
- MSF-nutcon03
- Acronym
- MSF-nutcon03
- Status last verified
- Jun 2015
- First submitted
- 20 Dec 2011
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Kam S, Roll S, Swarthout T, Edyegu-Otelu G, Matsumoto A, Kasujja FX, Casademont C, Shanks L, Salse-Ubach N. 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 Uganda. PLoS Med. 2016 Feb 9;13(2):e1001951. doi: 10.1371/journal.pmed.1001951. eCollection 2016 Feb.
PubMed 26859481
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. 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 Kaabong, Karamoja, Uganda
- ClinicalTrials.gov ID
- NCT01497236
- Acronym / sponsor ID
- MSF-nutcon03 / MSF-nutcon03
- Conditions
- Child Malnutrition, Infant Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,202 participants (actual)
- Lead sponsor
- Medecins Sans Frontieres, SpainUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Dec 2011 (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
similar to MSF-nutcon 03 : NCT01154803
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Ready to Use Terapeutic Food (RUTF) | Experimental | Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP |
| Multi Micronutrient Powder (MNP) | Experimental | Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP |
| no supplement | No intervention | – |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 6 to 59 months of age
- Not malnourished
- 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 |
|---|---|---|
| Dietary Supplement: Nutrition supplement with RUTF or MNPAlso: Other Names:, RUTF: Nutriset, MNP: MixMe, DSM, Placebo: DSM14 days nutritional supplementation with either * a fortified high quality food(RUTF), 1 sachet/day, 500 kcal and multi micronutrients * a multi micronutrient powder (MNP), 2 sachets per day, no calories, twice recommended daily intake * a placebo (to MNP), 2 sachets per day , no calories, no micronutrients, containing micronutrient carrier | Dietary supplement | Experimental: Ready to Use Terapeutic Food (RUTF), Multi 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 30 Jun 2015.
- Derived from this study: PubMed 26859481van der Kam S, Roll S, Swarthout T, Edyegu-Otelu G, Matsumoto A, Kasujja FX, Casademont C, Shanks L, Salse-Ubach N. 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 Uganda. PLoS Med. 2016 Feb 9;13(2):e1001951. doi: 10.1371/journal.pmed.1001951. 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.
Nuria Salse principal investigator
MSF Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Nutrition supplement with RUTF or MNP in people with Child Malnutrition and Infant Morbidity, run by Medecins Sans Frontieres, Spain at 1 site in Uganda.
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 30 Jun 2015. 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 Uganda. 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 NCT01497236, 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 30 Jun 2015.