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Severe Acute MalnutritionNCT02994212

Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety

A study testing Monthly distribution of RUTF in people with Severe Acute Malnutrition, run by Epicentre.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Community-based management of severe acute malnutrition (SAM) has been shown to be safe and cost-effective, but program coverage remains low. New treatment models that maintain high levels of clinical effectiveness but allow for increased coverage are still needed. Read more about this study

Who is it for?
Ages 6 to 59 months
Conditions the study is for
Severe Acute Malnutrition
What is being tested?
Monthly distribution of RUTF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
No sites listed yet
Study dates
Jul 2014to Nov 2014
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

  • a) being eligible for new admission to treatment of uncomplicated SAM
  • b) being resident within 15 km of the study health center

Who cannot join

  • previously default from previous SAM treatment (e.g. missed 2 consecutive weekly visits)
  • considered a relapse case (e.g. re-admitted within three months of previous discharge)

About this study

Official title: Reduced Frequency of Visits in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety

Community-based management of severe acute malnutrition (SAM) has been shown to be safe and cost-effective, but program coverage remains low. New treatment models that maintain high levels of clinical effectiveness but allow for increased coverage are still needed. A reduced schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot intervention study in which 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm circumference) MUAC gain, weight loss > 5%, and the development of edema. Unannounced household spot checks were conducted over 4 weeks to assess household utilization of RUTF and storage practices.

Being tested
Monthly distribution of RUTF
Medical subject headings
Severe Acute Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monthly distribution of RUTFDietary supplement

    115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.

Study groups in NCT02994212
Study groupRoleWhat they receive
Intervention groupExperimental115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response.
Receives: Dietary Supplement: Monthly distribution of RUTF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. weight gain

    grams/kilograms/day gained

    Measured: 4 weeks

  2. mid-upper arm circumference gain (mm/day)

    millimeters gained per day

    Measured: 4 weeks

  3. weight loss > 5%

    Measured: 4 weeks

  4. development of edema

    Measured: 4 weeks

Secondary outcomes (1)

  1. correct utilization of RUTF

    > 2 sachets deviance between available and expected RUTF stocks at unannounced household visits

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2016 (estimated)
  2. Study startJul 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02994212
Sponsor's protocol ID
821414-1
Status last verified
Dec 2019
First submitted
13 Dec 2016
Last updated
4 Dec 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Isanaka S, Kodish SR, Berthe F, Alley I, Nackers F, Hanson KE, Grais RF. Outpatient treatment of severe acute malnutrition: response to treatment with a reduced schedule of therapeutic food distribution. Am J Clin Nutr. 2017 May;105(5):1191-1197. doi: 10.3945/ajcn.116.148064. Epub 2017 Apr 12.

    PubMed 28404577

Questions about this trial

What is this clinical trial studying?

A study testing Monthly distribution of RUTF in people with Severe Acute Malnutrition, run by Epicentre.

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 2 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 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

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: 4 weeks). The study lists 4 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 NCT02994212, 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 4 Dec 2019.

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