MalnutritionHi-MAMNCT03647150
Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria
A study testing amoxicillin, Ready-to-use therapeutic food (RUTF) and Mother Care group in people with Malnutrition, run by Washington University School of Medicine at 1 site in Sierra Leone.
Trial summary
This project explores whether children have better growth and cognitive development when the clinic identifies "higher risk" MAM children and support them either with the same treatment as SAM children or with the recommended practice: nutrition counseling. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malnutrition
- What is being tested?
- amoxicillin, Ready-to-use therapeutic food (RUTF) and Mother Care group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,322 participants
- Where
- 1 siteSierra Leone
- Study dates
- 13 Nov 2018to 5 Jun 2020
- 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
- uncomplicated MAM (based on MUAC equal to or greater than 11.5 cm and <12.5)
Who cannot join
- currently involved in another research trial or feeding program
- medical complication such as oedema, severe nausea/vomiting, severe dehydration, or severe pneumonia
- have a diagnosed or visible sign of developmental delay
- have a history of peanut or milk allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM Study): A Cluster-randomized Controlled Trial Protocol
This project explores whether children have better growth and cognitive development when the clinic identifies "higher risk" MAM children and support them either with the same treatment as SAM children or with the recommended practice: nutrition counseling.
Read the detailed description
This is a cluster-randomized controlled trial taking place in 20 community clinics providing malnutrition care in Sierra Leone.
All participants will be children aged 6-59 months. Control participants will have moderate acute malnutrition (MAM), defined as mid-upper arm circumference (MUAC) 11.5-<12.5. High Risk MAM will be defined with a MUAC 11.5 to <11.9 or WAZ<-3.5 or Mother not the caretaker or not breastfeeding at <2 years old. Low risk MAM defined with a MUAC 11.9 to <12.5 with no risk factors.
Control group and low risk group caregiver's will received nutrition education via mother care groups every two weeks for 6 weeks and will be followed up 12 and 24 weeks post-enrollment.
High risk group will receive 1 week supply of amoxicillin at enrollment and 1 sachet of RUTF per day till MUAC is equal to or greater than 12.5 or up to 12 weeks of treatment. Their caregiver will also receive nutrition education via the mother care groups. The investigators will also follow up with the participant at 12 and 24 weeks post-enrollment.
A subset of the participants in each group will also be enrolled in a cognitive development substudy were the investigators will be using a eye tracking performance assessment. Investigators will also enroll health adult participants for eye tracking assessment. Adult data will be used as a reference when interpreting results.
- Conditions
- Malnutrition
- Being tested
- amoxicillin, Ready-to-use therapeutic food (RUTF), Mother Care group
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillinDrug
At enrollment the child will receive a 1 week course of amoxicillin
Ready-to-use therapeutic food (RUTF)Dietary supplement
1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed
Mother Care groupBehavioural
Nutrition education via mother care groups lead by a respected elder in the local community
| Study group | Role | What they receive |
|---|---|---|
| Moderate Acute Malnutrition (MAM) | Other | MAM children at control clinics or MAM children at intervention clinics that do no have high rick characteristics. Control treatment is "Mother Care" counselling, delivered by a respected elder in the local community. Receives: Behavioral: Mother Care group |
| High Risk Moderate Acute Malnutrition (MAM) | Experimental | The intervention treatment incorporates Mother Care counselling, provision of one packet (508 calories) of ready-to-use therapeutic food (RUTF) daily and a 1 week course of amoxicillin. This provision will continue until the child has reached a mid-upper arm circumference (MUAC) equal to or greater than 12.5 cm or 12 weeks have elapsed. Receives: Drug: amoxicillin; Dietary Supplement: Ready-to-use therapeutic food (RUTF); Behavioral: Mother Care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery from moderate acute malnutrition (MAM)
proportion of participants recovered based on mid-upper arm circumference(MUAC) Recovery is defined as MUAC greater than or equal to 12.5cm before or at 12 weeks after enrollment.
Measured: up to 12 weeks of treatment
Secondary outcomes (6)
Participant survival rates
Proportion of participants survival rates during the study
Measured: Duration of the study 24 weeks post-enrollment
Participants deterioration to severe acute malnutrition(SAM)
Proportion of participants that deteriorate from moderate acute malnutrition(MAM) to severe acute malnutrition(SAM). SAM is defined at mid-upper arm circumference(MUAC)<11.5 or presence of oedema.
Measured: Duration of the study 24 weeks post-enrollment
Participants that remain or become underweight using weight for age z-score
the difference between the weight for age z-score(WAZ) from enrollment to 24 weeks post-enrollment
Measured: 24 weeks post-enrollment
Participants that remain or become Stunted
the difference between length for age z-score(LAZ) from enrollment to 24 weeks post enrollment
Measured: 24 weeks post-enrollment
Participants that remain or become Wasted
the difference between weight for length z-score(WHL) from enrollment to 24 weeks post enrollment
Measured: 24 weeks post-enrollment
Eye tracking performance for cognitive development
the difference between the eye tracking performance from enrollment to 24 weeks post enrollment
Measured: 24 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start13 Nov 2018
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- 1,322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Global Child Health, Hospital for Sick Kids, Toronto, Canada, Department of Psychology, University of Tampere, Finland, Project Peanut Butter, Sierra Leone
- Responsible party
- Sponsor
- Investigators
- Mark Manary, MD, Principal investigator, Washington University School of Medicine in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647150
- Sponsor's protocol ID
- 201807153
- Acronym
- Hi-MAM
- Status last verified
- Aug 2020
- First submitted
- 31 Jul 2018
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joshua GE, Jadhav M, Bhaktaviziam A, Mokashi S. Mental retardation in children. II. Leucodystrophies. Indian Pediatr. 1974 Jan;11(1):53-9. No abstract available.
PubMed 4839581Lenters LM, Wazny K, Webb P, Ahmed T, Bhutta ZA. Treatment of severe and moderate acute malnutrition in low- and middle-income settings: a systematic review, meta-analysis and Delphi process. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S23. doi: 10.1186/1471-2458-13-S3-S23. Epub 2013 Sep 17.
PubMed 24564235Chang CY, Trehan I, Wang RJ, Thakwalakwa C, Maleta K, Deitchler M, Manary MJ. Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery. J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19.
PubMed 23256140Maust A, Koroma AS, Abla C, Molokwu N, Ryan KN, Singh L, Manary MJ. Severe and Moderate Acute Malnutrition Can Be Successfully Managed with an Integrated Protocol in Sierra Leone. J Nutr. 2015 Nov;145(11):2604-9. doi: 10.3945/jn.115.214957. Epub 2015 Sep 30.
PubMed 26423737Ekelund U, Ong KK, Linne Y, Neovius M, Brage S, Dunger DB, Wareham NJ, Rossner S. Association of weight gain in infancy and early childhood with metabolic risk in young adults. J Clin Endocrinol Metab. 2007 Jan;92(1):98-103. doi: 10.1210/jc.2006-1071. Epub 2006 Oct 10.
PubMed 17032722Khara T, Mwangome M, Ngari M, Dolan C. Children concurrently wasted and stunted: A meta-analysis of prevalence data of children 6-59 months from 84 countries. Matern Child Nutr. 2018 Apr;14(2):e12516. doi: 10.1111/mcn.12516. Epub 2017 Sep 25.
PubMed 28944990Schofield C, Ashworth A. Why have mortality rates for severe malnutrition remained so high? Bull World Health Organ. 1996;74(2):223-9.
PubMed 8706239Lelijveld N, Godbout C, Krietemeyer D, Los A, Wegner D, Hendrixson DT, Bandsma R, Koroma A, Manary M. Treating high-risk moderate acute malnutrition using therapeutic food compared with nutrition counseling (Hi-MAM Study): a cluster-randomized controlled trial. Am J Clin Nutr. 2021 Sep 1;114(3):955-964. doi: 10.1093/ajcn/nqab137.
PubMed 33963734
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM Study): A Cluster-randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT03647150
- Acronym / sponsor ID
- Hi-MAM / 201807153
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,322 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Centre for Global Child Health, Hospital for Sick Kids, Toronto, Canada, Department of Psychology, University of Tampere, Finland, Project Peanut Butter, Sierra Leone
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- 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.
This project explores whether children have better growth and cognitive development when the clinic identifies "higher risk" MAM children and support them either with the same treatment as SAM children or with the recommended practice: nutrition counseling.
Detailed description
This is a cluster-randomized controlled trial taking place in 20 community clinics providing malnutrition care in Sierra Leone.
All participants will be children aged 6-59 months. Control participants will have moderate acute malnutrition (MAM), defined as mid-upper arm circumference (MUAC) 11.5-<12.5. High Risk MAM will be defined with a MUAC 11.5 to <11.9 or WAZ<-3.5 or Mother not the caretaker or not breastfeeding at <2 years old. Low risk MAM defined with a MUAC 11.9 to <12.5 with no risk factors.
Control group and low risk group caregiver's will received nutrition education via mother care groups every two weeks for 6 weeks and will be followed up 12 and 24 weeks post-enrollment.
High risk group will receive 1 week supply of amoxicillin at enrollment and 1 sachet of RUTF per day till MUAC is equal to or greater than 12.5 or up to 12 weeks of treatment. Their caregiver will also receive nutrition education via the mother care groups. The investigators will also follow up with the participant at 12 and 24 weeks post-enrollment.
A subset of the participants in each group will also be enrolled in a cognitive development substudy were the investigators will be using a eye tracking performance assessment. Investigators will also enroll health adult participants for eye tracking assessment. Adult data will be used as a reference when interpreting results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Acute Malnutrition (MAM) | Other | Behavioral: Mother Care groupMAM children at control clinics or MAM children at intervention clinics that do no have high rick characteristics. Control treatment is "Mother Care" counselling, delivered by a respected elder in the local community. |
| High Risk Moderate Acute Malnutrition (MAM) | Experimental | Drug: amoxicillin, Dietary Supplement: Ready-to-use therapeutic food (RUTF), Behavioral: Mother Care groupThe intervention treatment incorporates Mother Care counselling, provision of one packet (508 calories) of ready-to-use therapeutic food (RUTF) daily and a 1 week course of amoxicillin. This provision will continue until the child has reached a mid-upper arm circumference (MUAC) equal to or greater than 12.5 cm or 12 weeks have elapsed. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- uncomplicated MAM (based on MUAC equal to or greater than 11.5 cm and <12.5)
Key exclusion criteria (4 listed)
- currently involved in another research trial or feeding program
- medical complication such as oedema, severe nausea/vomiting, severe dehydration, or severe pneumonia
- have a diagnosed or visible sign of developmental delay
- have a history of peanut or milk allergy
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 |
|---|---|---|
| amoxicillinAt enrollment the child will receive a 1 week course of amoxicillin | Drug | High Risk Moderate Acute Malnutrition (MAM) |
| Ready-to-use therapeutic food (RUTF)1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed | Dietary supplement | High Risk Moderate Acute Malnutrition (MAM) |
| Mother Care groupNutrition education via mother care groups lead by a respected elder in the local community | Behavioural | High Risk Moderate Acute Malnutrition (MAM), Moderate Acute Malnutrition (MAM) |
Primary outcome
Recovery from moderate acute malnutrition (MAM)
Time frame: up to 12 weeks of treatment
proportion of participants recovered based on mid-upper arm circumference(MUAC) Recovery is defined as MUAC greater than or equal to 12.5cm before or at 12 weeks after enrollment.
6 secondary outcomes
Participant survival rates
Time frame: Duration of the study 24 weeks post-enrollment
Participants deterioration to severe acute malnutrition(SAM)
Time frame: Duration of the study 24 weeks post-enrollment
Participants that remain or become underweight using weight for age z-score
Time frame: 24 weeks post-enrollment
Participants that remain or become Stunted
Time frame: 24 weeks post-enrollment
Participants that remain or become Wasted
Time frame: 24 weeks post-enrollment
Eye tracking performance for cognitive development
Time frame: 24 weeks post enrollment
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 1 Sep 2020.
- Background: PubMed 4839581Joshua GE, Jadhav M, Bhaktaviziam A, Mokashi S. Mental retardation in children. II. Leucodystrophies. Indian Pediatr. 1974 Jan;11(1):53-9. No abstract available.
- Background: PubMed 24564235Lenters LM, Wazny K, Webb P, Ahmed T, Bhutta ZA. Treatment of severe and moderate acute malnutrition in low- and middle-income settings: a systematic review, meta-analysis and Delphi process. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S23. doi: 10.1186/1471-2458-13-S3-S23. Epub 2013 Sep 17.
- Background: PubMed 23256140Chang CY, Trehan I, Wang RJ, Thakwalakwa C, Maleta K, Deitchler M, Manary MJ. Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery. J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19.
- Background: PubMed 26423737Maust A, Koroma AS, Abla C, Molokwu N, Ryan KN, Singh L, Manary MJ. Severe and Moderate Acute Malnutrition Can Be Successfully Managed with an Integrated Protocol in Sierra Leone. J Nutr. 2015 Nov;145(11):2604-9. doi: 10.3945/jn.115.214957. Epub 2015 Sep 30.
- Background: PubMed 17032722Ekelund U, Ong KK, Linne Y, Neovius M, Brage S, Dunger DB, Wareham NJ, Rossner S. Association of weight gain in infancy and early childhood with metabolic risk in young adults. J Clin Endocrinol Metab. 2007 Jan;92(1):98-103. doi: 10.1210/jc.2006-1071. Epub 2006 Oct 10.
- Background: PubMed 28944990Khara T, Mwangome M, Ngari M, Dolan C. Children concurrently wasted and stunted: A meta-analysis of prevalence data of children 6-59 months from 84 countries. Matern Child Nutr. 2018 Apr;14(2):e12516. doi: 10.1111/mcn.12516. Epub 2017 Sep 25.
- Background: PubMed 8706239Schofield C, Ashworth A. Why have mortality rates for severe malnutrition remained so high? Bull World Health Organ. 1996;74(2):223-9.
- Derived from this study: PubMed 33963734Lelijveld N, Godbout C, Krietemeyer D, Los A, Wegner D, Hendrixson DT, Bandsma R, Koroma A, Manary M. Treating high-risk moderate acute malnutrition using therapeutic food compared with nutrition counseling (Hi-MAM Study): a cluster-randomized controlled trial. Am J Clin Nutr. 2021 Sep 1;114(3):955-964. doi: 10.1093/ajcn/nqab137.
- United Nations Department of Economic and Social Affairs, P.D. World Population Prospectus 2017. 2017Link provided by the sponsor.
- WHO. IMCI chart booklet. 2014Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mark Manary, MD principal investigator
Washington University School of Medicine in St. Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amoxicillin, Ready-to-use therapeutic food (RUTF) and Mother Care group in people with Malnutrition, run by Washington University School of Medicine 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 1 inclusion and 4 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 1 Sep 2020. 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 from moderate acute malnutrition (MAM) (time frame: up to 12 weeks of treatment). 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 NCT03647150, which also lists 8 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 1 Sep 2020.