MalnutritionNCT02351687
Package of Interventions After Recovering From Moderate Acute Malnutrition
A study testing Lipid Nutrient Supplement, Sulfadoxine-pyrimethamine and Albendazole in people with Malnutrition, run by Washington University School of Medicine at 1 site in Malawi.
Trial summary
Children who recover from moderate acute malnutrition in Malawi remain at high risk for relapse or death in the year following recovery. This cluster-randomized trial will evaluate a package of affordable, safe, proven interventions specifically targeted to this population of children in an attempt to decrease their… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malnutrition
- What is being tested?
- Lipid Nutrient Supplement, Sulfadoxine-pyrimethamine and Albendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,499 participants
- Where
- 1 siteMalawi
- Study dates
- Apr 2014to Jun 2016
- 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
- recovered from moderate acute malnutrition, as defined by mid-upper arm circumference (MUAC) of 11.5-12.4 cm
Who cannot join
- not permanent resident in vicinity of site
- severe chronic illness
- receiving other supplementary food or participating in other research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of the Impact of Offering a Nutrition and Health Intervention to Children Recovered From Moderate Acute Malnutrition
Children who recover from moderate acute malnutrition in Malawi remain at high risk for relapse or death in the year following recovery. This cluster-randomized trial will evaluate a package of affordable, safe, proven interventions specifically targeted to this population of children in an attempt to decrease their risk of relapse or death following recovery from moderate acute malnutrition. These children will be followed for a year following recovery to assess rates of relapse and mortality.
- Conditions
- Malnutrition
- Being tested
- Lipid Nutrient Supplement, Sulfadoxine-pyrimethamine, Albendazole, Zinc, Insecticide-treated bednet
- Keywords
- Moderate Acute Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid Nutrient SupplementDietary supplement
Sulfadoxine-pyrimethamineDrug
AlbendazoleDrug
ZincDrug
Insecticide-treated bednetOther
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | No specific intervention given after recovery from moderate acute malnutrition. |
| Package of interventions | Experimental | Package of interventions given after recovery from moderate acute malnutrition -- includes lipid-nutrient supplement for 2 months, malaria chemoprophylaxis for 3 months during malaria season, an insecticide-treated bed net, a one-time albendazole treatment, and 14 days of zinc. Receives: Dietary Supplement: Lipid Nutrient Supplement; Drug: Sulfadoxine-pyrimethamine; Drug: Albendazole; Drug: Zinc; Other: Insecticide-treated bednet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema)
Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malawi
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351687
- Sponsor's protocol ID
- MFU2014
- Status last verified
- Nov 2016
- First submitted
- 21 Jan 2015
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Stobaugh HC, Rogers BL, Rosenberg IH, Webb P, Maleta KM, Manary MJ, Trehan I. Children with Poor Linear Growth Are at Risk for Repeated Relapse to Wasting after Recovery from Moderate Acute Malnutrition. J Nutr. 2018 Jun 1;148(6):974-979. doi: 10.1093/jn/nxy033.
PubMed 29726948Stobaugh HC, Bollinger LB, Adams SE, Crocker AH, Grise JB, Kennedy JA, Thakwalakwa C, Maleta KM, Dietzen DJ, Manary MJ, Trehan I. Effect of a package of health and nutrition services on sustained recovery in children after moderate acute malnutrition and factors related to sustaining recovery: a cluster-randomized trial. Am J Clin Nutr. 2017 Aug;106(2):657-666. doi: 10.3945/ajcn.116.149799. Epub 2017 Jun 14.
PubMed 28615258
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Impact of Offering a Nutrition and Health Intervention to Children Recovered From Moderate Acute Malnutrition
- ClinicalTrials.gov ID
- NCT02351687
- Acronym / sponsor ID
- MFU2014
- Conditions
- Malnutrition
- Keywords
- Moderate Acute Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,499 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Malawi
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jan 2015 (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.
Children who recover from moderate acute malnutrition in Malawi remain at high risk for relapse or death in the year following recovery. This cluster-randomized trial will evaluate a package of affordable, safe, proven interventions specifically targeted to this population of children in an attempt to decrease their risk of relapse or death following recovery from moderate acute malnutrition. These children will be followed for a year following recovery to assess rates of relapse and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –No specific intervention given after recovery from moderate acute malnutrition. |
| Package of interventions | Experimental | Dietary Supplement: Lipid Nutrient Supplement, Drug: Sulfadoxine-pyrimethamine, Drug: Albendazole, Drug: Zinc, Other: Insecticide-treated bednetPackage of interventions given after recovery from moderate acute malnutrition -- includes lipid-nutrient supplement for 2 months, malaria chemoprophylaxis for 3 months during malaria season, an insecticide-treated bed net, a one-time albendazole treatment, and 14 days of zinc. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- recovered from moderate acute malnutrition, as defined by mid-upper arm circumference (MUAC) of 11.5-12.4 cm
Key exclusion criteria (3 listed)
- not permanent resident in vicinity of site
- severe chronic illness
- receiving other supplementary food or participating in other research
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 |
|---|---|---|
| Lipid Nutrient Supplement | Dietary supplement | Package of interventions |
| Sulfadoxine-pyrimethamine | Drug | Package of interventions |
| Albendazole | Drug | Package of interventions |
| Zinc | Drug | Package of interventions |
| Insecticide-treated bednet | Other | Package of interventions |
Primary outcome
Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema)
Time frame: 12 months
Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema
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 10 Nov 2016.
- Derived from this study: PubMed 29726948Stobaugh HC, Rogers BL, Rosenberg IH, Webb P, Maleta KM, Manary MJ, Trehan I. Children with Poor Linear Growth Are at Risk for Repeated Relapse to Wasting after Recovery from Moderate Acute Malnutrition. J Nutr. 2018 Jun 1;148(6):974-979. doi: 10.1093/jn/nxy033.
- Derived from this study: PubMed 28615258Stobaugh HC, Bollinger LB, Adams SE, Crocker AH, Grise JB, Kennedy JA, Thakwalakwa C, Maleta KM, Dietzen DJ, Manary MJ, Trehan I. Effect of a package of health and nutrition services on sustained recovery in children after moderate acute malnutrition and factors related to sustaining recovery: a cluster-randomized trial. Am J Clin Nutr. 2017 Aug;106(2):657-666. doi: 10.3945/ajcn.116.149799. Epub 2017 Jun 14.
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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 J Manary, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid Nutrient Supplement, Sulfadoxine-pyrimethamine and Albendazole in people with Malnutrition, run by Washington University School of Medicine at 1 site in Malawi.
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 3 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 10 Nov 2016. 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 Malawi. 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?
Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema) (time frame: 12 months). 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 NCT02351687, which also lists 2 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 10 Nov 2016.