Moderate Acute MalnutritionNCT01147198
Ready to Use Supplementary Food in Moderate Childhood Malnutrition
A study testing Ready to Use Supplementary Food and Premix CSB-oil treatment in people with Moderate Acute Malnutrition, run by Medecins Sans Frontieres, Netherlands at 1 site in Sierra Leone.
Trial summary
Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe malnutrition. Their efficacy and effectiveness were proven in community therapeutic care programs. Recently, the question rose if RUTF would be more effective than enriched flours to treat moderate malnutrition. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Moderate Acute Malnutrition
- What is being tested?
- Ready to Use Supplementary Food and Premix CSB-oil treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteSierra Leone
- Study dates
- Apr 2007to Apr 2008
- 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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all children aged 6 months to 5 years admitted to SFC outpatient care during the study period
- WHM between 70-79% (1977 NCHS/WHO standard) without edema
- approval from the caretaker
Who cannot join
- presence of the following signs: bilateral edema, MUAC<110 mm , WHM< 70%(criteria for severe malnutrition), and medical complications necessitating hospitalisation
- refusal to participate from caretaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Ready-to-Use-Supplementary-Food for the Treatment of Moderate Childhood Malnutrition
Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe malnutrition. Their efficacy and effectiveness were proven in community therapeutic care programs. Recently, the question rose if RUTF would be more effective than enriched flours to treat moderate malnutrition.
The purpose of this study is to compare the effectiveness of Ready to Use Food Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain, duration of treatment, morbidity and mortality in the treatment of moderate acute malnutrition.
Compare the longer term effect on nutritional status and morbidity (relapse?).
- Conditions
- Moderate Acute Malnutrition
- Being tested
- Ready to Use Supplementary Food, Premix CSB-oil treatment
- Keywords
- Moderate, Wasting, Malnutrition, Ready to Use Food, Fortified Blended Flour
- Medical subject headings
- Lymphoma, Follicular, Cachexia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready to Use Supplementary FoodDietary supplement
Also called Supplementary-plumpy®
Children received two Supplementary-plumpy® packages per day (184g) providing 1000 Kcal, 26g (10.4%) protein, 68g (61.2%) fat, and 100% of micronutrient requirements based on the Daily Recommended Nutrient Intake.
Premix CSB-oil treatmentDietary supplement
Also called Corn Soy Blend, Fortified Blended Flours
Children received 2 kg of premix per week (226g CSB, 37g oil, and 23g sugar / day) providing 1277 Kcal, 40.7g protein (12.7%), 50.6g (35.7%) fat, and 100% of micronutrient according to the DRNI guidelines
| Study group | Role | What they receive |
|---|---|---|
| Ready to Use Supplementary Food | Active comparator | Ready to Use Supplementary Food treatment Receives: Dietary Supplement: Ready to Use Supplementary Food |
| Premix | Active comparator | Premix Corn Soy Blend-oil treatment Receives: Dietary Supplement: Premix CSB-oil treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery
proportion of children who recovered, defined as WHM> 85% for two consecutive weeks
Measured: 112 days
Secondary outcomes (3)
average weight gain
in g per kg of weight per day
Measured: 112 days
Duration of treatment
average length of stay in days.
Measured: 112 days
Morbidity
number of morbidity episodes during the treatment and six months thereafter
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startApr 2007
- Primary completionAug 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Acute 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medecins Sans Frontieres, Netherlands
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Nutriset, United Nations World Food Programme (WFP)
- Investigators
- Pascale Delchevalerie, Msc, Principal investigator, Medecins Sans Frontieres, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147198
- Sponsor's protocol ID
- MSFOCB1
- Status last verified
- Mar 2007
- First submitted
- 17 Jun 2010
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Ready-to-Use-Supplementary-Food for the Treatment of Moderate Childhood Malnutrition
- ClinicalTrials.gov ID
- NCT01147198
- Acronym / sponsor ID
- MSFOCB1
- Conditions
- Moderate Acute Malnutrition
- Keywords
- Moderate, Wasting, Malnutrition, Ready to Use Food, Fortified Blended Flour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- Medecins Sans Frontieres, NetherlandsUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Nutriset, United Nations World Food Programme (WFP)
- Study start
- Apr 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 22 Jun 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.
Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe malnutrition. Their efficacy and effectiveness were proven in community therapeutic care programs. Recently, the question rose if RUTF would be more effective than enriched flours to treat moderate malnutrition.
The purpose of this study is to compare the effectiveness of Ready to Use Food Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain, duration of treatment, morbidity and mortality in the treatment of moderate acute malnutrition.
Compare the longer term effect on nutritional status and morbidity (relapse?).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ready to Use Supplementary Food | Active comparator | Dietary Supplement: Ready to Use Supplementary FoodReady to Use Supplementary Food treatment |
| Premix | Active comparator | Dietary Supplement: Premix CSB-oil treatmentPremix Corn Soy Blend-oil treatment |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- all children aged 6 months to 5 years admitted to SFC outpatient care during the study period
- WHM between 70-79% (1977 NCHS/WHO standard) without edema
- approval from the caretaker
Key exclusion criteria (2 listed)
- presence of the following signs: bilateral edema, MUAC<110 mm , WHM< 70%(criteria for severe malnutrition), and medical complications necessitating hospitalisation
- refusal to participate from caretaker
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 Supplementary FoodAlso: Supplementary-plumpy®Children received two Supplementary-plumpy® packages per day (184g) providing 1000 Kcal, 26g (10.4%) protein, 68g (61.2%) fat, and 100% of micronutrient requirements based on the Daily Recommended Nutrient Intake. | Dietary supplement | Ready to Use Supplementary Food |
| Premix CSB-oil treatmentAlso: Corn Soy Blend, Fortified Blended FloursChildren received 2 kg of premix per week (226g CSB, 37g oil, and 23g sugar / day) providing 1277 Kcal, 40.7g protein (12.7%), 50.6g (35.7%) fat, and 100% of micronutrient according to the DRNI guidelines | Dietary supplement | Premix |
Primary outcome
Recovery
Time frame: 112 days
proportion of children who recovered, defined as WHM> 85% for two consecutive weeks
3 secondary outcomes
average weight gain
Time frame: 112 days
Duration of treatment
Time frame: 112 days
Morbidity
Time frame: 11 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 24 Jan 2012.
Related trials for Moderate Acute Malnutrition
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Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh
Moderate Acute Malnutrition (MAM), Undernutrition
Active, not recruiting
Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau
Severe Acute Malnutrition, Moderate Acute Malnutrition (MAM)
Not yet recruiting
Reduced Dosage and/or Visitation Protocol for the Treatment of Acute Malnutrition in Kenya
Acute Malnutrition in Childhood, Acute Malnutrition, Severe
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.
Pascale Delchevalerie, Msc principal investigator
Medecins Sans Frontieres, Netherlands
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 Supplementary Food and Premix CSB-oil treatment in people with Moderate Acute Malnutrition, run by Medecins Sans Frontieres, Netherlands at 1 site in Sierra Leone.
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 3 inclusion and 2 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 24 Jan 2012. 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 Sierra Leone. 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?
Recovery (time frame: 112 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2012.