Moderate Acute Malnutrition (MAM)Mali-MMAMNCT01015950
Management of Children With Moderate Acute Malnutrition in Mali
A study testing Plumpy'Sup, Local food supplement and Misola in people with Moderate Acute Malnutrition (MAM), run by Helen Keller International at 1 site in Mali.
Trial summary
The objectives of the study are to assess the impact of different dietary strategies for the management of children with MAM on: the children's continued participation in the nutritional rehabilitation program and their physical growth, recovery from MAM, and change in micronutrient status and body composition. Read more about this study
- Who is it for?
- Ages 6 to 35 months
- Conditions the study is for
- Moderate Acute Malnutrition (MAM)
- What is being tested?
- Plumpy'Sup, Local food supplement and Misola
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,260 participants
- Where
- 1 siteMali
- Study dates
- May 2010to Dec 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 35 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age from 6 to 35 months,
- MUAC <12.5 cm and >11.0 cm, and weight-for-length (WLZ) Z-score > -3.0 (WHO standard, 2006); or WLZ <-2.0 and >-3.0 and MUAC >11.0 cm
- absence of bi-pedal edema
- absence of current diseases requiring inpatient care
- expected availability during the period of the study
- residency within the study communities
- acceptance of home visitors, and
- written consent of a parent or guardian
Who cannot join
- age <6 months or >36 months
- MUAC >12.5 cm and WLZ >-2.0; or MUAC <11.0 cm; or WLZ <-3.0
- presence of bi-pedal edema,
- severe anemia (defined as hemoglobin <50 g/L),
- other acute illnesses requiring inpatient treatment,
- congenital abnormalities or underlying chronic diseases, including known HIV . infection, that may affect growth or risk of infection
- history of allergy towards peanuts or previous serious allergic reaction to . any substance, requiring emergency medical care
- concurrent participation in any other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Community-Based Effectiveness Trial of Selected Dietary Strategies for the Management of Young Malian Children With Moderate Acute Malnutrition (MAM) in the Context of the National Community Management of Acute Malnutrition
The objectives of the study are to assess the impact of different dietary strategies for the management of children with MAM on: the children's continued participation in the nutritional rehabilitation program and their physical growth, recovery from MAM, and change in micronutrient status and body composition. The specific dietary regimens that will be compared are: 1) a ready-to-use, lipid-based supplementary food (Plumpy'Sup, Nutriset, Inc.), providing ~500 kcal/d for 12 weeks; 2) specially formulated CSB for malnourished children, providing ~ 500 kcal/d for 12 weeks; 3) Misola, a locally produced, micronutrient-fortified, cereal-legume blend, providing ~500 kcal/d for 12 weeks; or 4) packaged, home available foods (millet and cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("Mix Me") for 12 weeks, as is currently recommended by the national CMAM protocol when special foods are not available.
- Conditions
- Moderate Acute Malnutrition (MAM)
- Being tested
- Plumpy'Sup, Local food supplement, Misola, SCSB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plumpy'SupDietary supplement
Also called Plumpy'Sup, Supplementary Plumpy, Nutriset, France
Lipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d
Local food supplementDietary supplement
Local foods (millet flour, cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("Mix Me") are provide, according to the national Mali CMAM protocol when special processed foods are not available.
MisolaDietary supplement
Also called Misola, Mali
Locally produced, millet-soy-peanut-based fortified complementary food (Misola)
SCSBDietary supplement
Also called World Food Program
Processed, fortified, corn-soy-milk-based food blend (SCSB for malnourished children, to be supplied by the World Food Program) to provide an additional 500 kcal/day
| Study group | Role | What they receive |
|---|---|---|
| Pumpy'Sup | Experimental | Lipid-based nutrient supplement Receives: Dietary Supplement: Plumpy'Sup |
| SCSB | Experimental | Processed, fortified, cereal-based food blend (SCSB for malnourished children) Receives: Dietary Supplement: SCSB |
| Misola | Experimental | Locally processed, fortified food blend (Misola) Receives: Dietary Supplement: Misola |
| Local food supplement | Active comparator | Local foods (millet flour, cowpea flour, sugar, oil) and a multiple micronutrient powder ("Mix-Me") are provided to simulate the currently recommended enhanced home-prepared rehabilitation food mixture ("farines enrchies") according to the national Mali CMAM protocol. Receives: Dietary Supplement: Local food supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 3 months
Continuation in treatment
Measured: 3 months
Secondary outcomes (2)
Micronutrient status
Measured: 3 months
Body composition
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startMay 2010
- Primary completionAug 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Moderate Acute Malnutrition (MAM)Studies 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
- 1,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Keller International
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bamako, University of California, Davis, UNICEF, United Nations World Food Programme (WFP)
- Responsible party
- Sponsor
- Investigators
- Kenneth H Brown, MD, Principal investigator, Helen Keller International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015950
- Sponsor's protocol ID
- 200917501-1, 200917501-2
- Acronym
- Mali-MMAM
- Status last verified
- Aug 2019
- First submitted
- 17 Nov 2009
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Isanaka S, Barnhart DA, McDonald CM, Ackatia-Armah RS, Kupka R, Doumbia S, Brown KH, Menzies NA. Cost-effectiveness of community-based screening and treatment of moderate acute malnutrition in Mali. BMJ Glob Health. 2019 Apr 28;4(2):e001227. doi: 10.1136/bmjgh-2018-001227. eCollection 2019.
PubMed 31139441McDonald CM, Ackatia-Armah RS, Doumbia S, Kupka R, Duggan CP, Brown KH. Percent Fat Mass Increases with Recovery, But Does Not Vary According to Dietary Therapy in Young Malian Children Treated for Moderate Acute Malnutrition. J Nutr. 2019 Jun 1;149(6):1089-1096. doi: 10.1093/jn/nxz037.
PubMed 30968123Ackatia-Armah RS, McDonald CM, Doumbia S, Erhardt JG, Hamer DH, Brown KH. Malian children with moderate acute malnutrition who are treated with lipid-based dietary supplements have greater weight gains and recovery rates than those treated with locally produced cereal-legume products: a community-based, cluster-randomized trial. Am J Clin Nutr. 2015 Mar;101(3):632-45. doi: 10.3945/ajcn.113.069807. Epub 2015 Jan 7.
PubMed 25733649
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Community-Based Effectiveness Trial of Selected Dietary Strategies for the Management of Young Malian Children With Moderate Acute Malnutrition (MAM) in the Context of the National Community Management of Acute Malnutrition
- ClinicalTrials.gov ID
- NCT01015950
- Acronym / sponsor ID
- Mali-MMAM / 200917501-1, 200917501-2
- Conditions
- Moderate Acute Malnutrition (MAM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,260 participants (actual)
- Lead sponsor
- Helen Keller InternationalUniversity, hospital or other
- Collaborators
- University of Bamako, University of California, Davis, UNICEF, United Nations World Food Programme (WFP)
- Study start
- May 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Nov 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 objectives of the study are to assess the impact of different dietary strategies for the management of children with MAM on: the children's continued participation in the nutritional rehabilitation program and their physical growth, recovery from MAM, and change in micronutrient status and body composition. The specific dietary regimens that will be compared are: 1) a ready-to-use, lipid-based supplementary food (Plumpy'Sup, Nutriset, Inc.), providing ~500 kcal/d for 12 weeks; 2) specially formulated CSB for malnourished children, providing ~ 500 kcal/d for 12 weeks; 3) Misola, a locally produced, micronutrient-fortified, cereal-legume blend, providing ~500 kcal/d for 12 weeks; or 4) packaged, home available foods (millet and cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("Mix Me") for 12 weeks, as is currently recommended by the national CMAM protocol when special foods are not available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pumpy'Sup | Experimental | Dietary Supplement: Plumpy'SupLipid-based nutrient supplement |
| SCSB | Experimental | Dietary Supplement: SCSBProcessed, fortified, cereal-based food blend (SCSB for malnourished children) |
| Misola | Experimental | Dietary Supplement: MisolaLocally processed, fortified food blend (Misola) |
| Local food supplement | Active comparator | Dietary Supplement: Local food supplementLocal foods (millet flour, cowpea flour, sugar, oil) and a multiple micronutrient powder ("Mix-Me") are provided to simulate the currently recommended enhanced home-prepared rehabilitation food mixture ("farines enrchies") according to the national Mali CMAM protocol. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- age from 6 to 35 months,
- MUAC <12.5 cm and >11.0 cm, and weight-for-length (WLZ) Z-score > -3.0 (WHO standard, 2006); or WLZ <-2.0 and >-3.0 and MUAC >11.0 cm
- absence of bi-pedal edema
- absence of current diseases requiring inpatient care
- expected availability during the period of the study
Key exclusion criteria (8 listed)
- age <6 months or >36 months
- MUAC >12.5 cm and WLZ >-2.0; or MUAC <11.0 cm; or WLZ <-3.0
- presence of bi-pedal edema,
- severe anemia (defined as hemoglobin <50 g/L),
- other acute illnesses requiring inpatient treatment,
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 |
|---|---|---|
| Plumpy'SupAlso: Plumpy'Sup, Supplementary Plumpy, Nutriset, FranceLipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d | Dietary supplement | Pumpy'Sup |
| Local food supplementLocal foods (millet flour, cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("Mix Me") are provide, according to the national Mali CMAM protocol when special processed foods are not available. | Dietary supplement | Local food supplement |
| MisolaAlso: Misola, MaliLocally produced, millet-soy-peanut-based fortified complementary food (Misola) | Dietary supplement | Misola |
| SCSBAlso: World Food ProgramProcessed, fortified, corn-soy-milk-based food blend (SCSB for malnourished children, to be supplied by the World Food Program) to provide an additional 500 kcal/day | Dietary supplement | SCSB |
Primary outcome
Weight gain
Time frame: 3 months
Continuation in treatment
Time frame: 3 months
2 secondary outcomes
Micronutrient status
Time frame: 3 months
Body composition
Time frame: 3 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 28 Aug 2019.
- Derived from this study: PubMed 31139441Isanaka S, Barnhart DA, McDonald CM, Ackatia-Armah RS, Kupka R, Doumbia S, Brown KH, Menzies NA. Cost-effectiveness of community-based screening and treatment of moderate acute malnutrition in Mali. BMJ Glob Health. 2019 Apr 28;4(2):e001227. doi: 10.1136/bmjgh-2018-001227. eCollection 2019.
- Derived from this study: PubMed 30968123McDonald CM, Ackatia-Armah RS, Doumbia S, Kupka R, Duggan CP, Brown KH. Percent Fat Mass Increases with Recovery, But Does Not Vary According to Dietary Therapy in Young Malian Children Treated for Moderate Acute Malnutrition. J Nutr. 2019 Jun 1;149(6):1089-1096. doi: 10.1093/jn/nxz037.
- Derived from this study: PubMed 25733649Ackatia-Armah RS, McDonald CM, Doumbia S, Erhardt JG, Hamer DH, Brown KH. Malian children with moderate acute malnutrition who are treated with lipid-based dietary supplements have greater weight gains and recovery rates than those treated with locally produced cereal-legume products: a community-based, cluster-randomized trial. Am J Clin Nutr. 2015 Mar;101(3):632-45. doi: 10.3945/ajcn.113.069807. Epub 2015 Jan 7.
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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.
Kenneth H Brown, MD principal investigator
Helen Keller International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plumpy'Sup, Local food supplement and Misola in people with Moderate Acute Malnutrition (MAM), run by Helen Keller International at 1 site in Mali.
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 8 inclusion and 8 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 28 Aug 2019. 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 Mali. 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: 3 months). The study lists 2 primary outcomes in all. 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 NCT01015950, which also lists 3 linked publications.
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 28 Aug 2019.