AzTrials
AzTrials

Moderate Acute Malnutrition (MAM)NCT02077907

Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition (MAM) in Children in Sierra Leone: a Cluster-randomised, Controlled Clinical Effectiveness Trial

A study testing Super Cereal Plus (SC+), Super Cereal (SC), fortified oil, sugar and Plumpy Sup in people with Moderate Acute Malnutrition (MAM), run by Tufts University.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The objective of this study is to test and compare the effectiveness and cost-effectiveness of four supplementary foods for the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone. Read more about this study

Who is it for?
Ages 6 to 59 monthsHealthy volunteers can take part
Conditions the study is for
Moderate Acute Malnutrition (MAM)
What is being tested?
Super Cereal Plus (SC+), Super Cereal (SC), fortified oil, sugar and Plumpy Sup
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,147 participants
Where
No sites listed yet
Study dates
Jan 2014to Jul 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
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Child diagnosed with MAM and enrolled to receive a ration from a feeding site (i.e. enrolled in the SFP) Exclusion Criteria
  • Children with bipedal oedema
  • Children receiving food rations from another organization (e.g. USAID or UNICEF)
  • Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children 6 months to 59 months old)
  • Beneficiary Mother/Caretaker whose child is diagnosed with MAM and enrolled to receive a ration from a feeding site
  • Beneficiary Mother/Caretaker has no age restrictions for inclusion (Note: Mothers/caretakers will be asked to participate regardless of age and consented appropriately; it is possible some mothers may be minors)
  • Subject who is voluntarily willing to participate and indicates by signing (or marking with a thumbprint) the consent form.

Who cannot join

  • Beneficiary Mothers/Caretakers who participate in an interview, observation or FGD once for this study will not be eligible again for participation
  • Community Health Volunteers (CHV)/Health Development Committee Members (HDC) Inclusion Criteria
  • Community Health Volunteers \& Health Development Committee Members serving within the catchment area for the PHUs
  • Community Health Volunteers that have been present during the study period
  • Subject who is voluntarily willing to participate and indicates by signing the consent form
  • PPB and Clinic Staff Members Inclusion Criteria
Show all 13Show fewer
  • All staff members from Project Peanut Butter and the PHU who are directly involved in the feeding program
  • Subject who is voluntarily willing to participate and indicates by signing the consent form Exclusion Criteria
  • Staff members who joined too recently to have experience of the program change (new commodities)
  • Village Elders/Headmen Inclusion Criteria
  • Village elder/headmen in study commune
  • Subject who is voluntarily willing to participate and indicates by signing the consent form Exclusion Criteria
  • Village elder/headmen whose community is not involved in the feeding program

About this study

The objective of this study is to test and compare the effectiveness and cost-effectiveness of four supplementary foods for the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone. Study participants will receive one of four test foods varying in energy and nutrient density as well as amounts provided.

  1. Super Cereal Plus (SC+) at 800 kcal/d, 215 g/d (Control group)
  2. Super Cereal (SC) and oil and sugar at 998 kcal/d - 200 g SC and 20 g oil and 20 g sugar, per day
  3. Corn-soy Blend 14 (CSB14) and oil at 978 kcal/day - 150 g CSB14 and 45 g oil, per day
  4. Plumpy'Sup - 500 kcal/d, 92 g/d
Read more

This will be a prospective, randomised, controlled effectiveness trial.

Aims

  1. (Impact) To compare the effectiveness of four supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone.
  2. (Cost) To estimate the relative cost-effectiveness (marginal cost per child recovered from MAM, relative to comparison group, SC+) of implementing the feeding program using each commodity, taking into consideration costs of procurement/production and distribution
  3. (Process) To evaluate the determinants of effectiveness including: consumption adherence, preparation compliance, targeting/sharing of supplement, food components and preparation, adverse effects of foods, water contamination, hygiene and health behaviors, SES, food security, perceived barriers

Outcomes

  1. Recovery from MAM
  2. Percent of children recovered from MAM (defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm by 12 weeks once)
  3. Percent default/non-response: children who do not recover after 12 weeks
  4. Percent relapse: children who become MAM again within 6 months of recovery
  5. Mean number of weeks to recovery

Hypothesis The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup will have similar recovery outcomes to those children fed Super Cereal Plus.

Null: The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup will have different recovery outcomes to those children fed Super Cereal Plus.

Being tested
Super Cereal Plus (SC+), Super Cereal (SC), fortified oil, sugar, Plumpy Sup, Corn Soy Blend 14 (CSB14) and fortified oil

What participants receive

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

  • Super Cereal Plus (SC+)Dietary supplement

  • Super Cereal (SC), fortified oil, sugarDietary supplement

  • Plumpy SupDietary supplement

  • Corn Soy Blend 14 (CSB14) and fortified oilDietary supplement

Study groups in NCT02077907
Study groupRoleWhat they receive
Super Cereal Plus (SC+)Active comparator800 kcal/d, 215 g/d Current protocol for treating MAM is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. In Sierra Leone, their FBF standard is Super Cereal Plus.
Receives: Dietary Supplement: Super Cereal Plus (SC+)
Super Cereal (SC) and oil and sugarExperimental200 g SC and 20 g fortified oil and 15 g sugar, per day Fortified blended food (FBF) Fortified Oil with Vitamins A \& D
Receives: Dietary Supplement: Super Cereal (SC), fortified oil, sugar
Corn Soy Blend 14 (CSB14) and fortified oilExperimental978 kcal/day - 150 g CSB14 and 45 g oil, per day Fortified blended food (FBF) Fortified Oil with Vitamins A \& D
Receives: Dietary Supplement: Corn Soy Blend 14 (CSB14) and fortified oil
Plumpy'SupExperimental500 kcal/d, 92 g/d Ready-to-Use Supplementary Food (RUSF)
Receives: Dietary Supplement: Plumpy Sup

What is being measured

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

  1. Recovery from MAM

    1. Percent of children recovered from MAM (defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm by 12 weeks once)
    2. Percent default/non-response: children who do not recover after 12 weeks
    3. Percent relapse: children who become MAM again within 6 months of recovery

    Measured: 12 weeks

Secondary outcomes (5)

  1. Change in Growth rates

    Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 6 months. At each clinic visit growth will be measured.

    Measured: 12 weeks

  2. Duration of treatment

    Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 6 months. Time to achieve MUAC of 12.5 cm will be documented.

    Measured: 12 weeks

  3. Cost estimates for participation

    Average cost of treatment will be measured per participant, this includes intervention costs and any medical costs needed by participants. The study costs no money to participants.

    Measured: 12 weeks

  4. Default reason

    If a child defaults, then the reason will be an outcome measure. Reasons to default include loss to follow-up (the child will be attempted to be contacted 3 times prior to being considered lost), death, or he/she enters into the inpatient clinic.

    Measured: 12 weeks

  5. Change in recovery status after 12 weeks

    Any changes in recovery will be measured at 6 months at follow-up visits

    Measured: 6 months

Timeline

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

  1. First posted4 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJul 2014

Why it stopped: Due to Ebola virus disease outbreak

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02077907
Sponsor's protocol ID
AID-016-Sierra Leone
Other IDs
USAID
Status last verified
Feb 2015
First submitted
28 Feb 2014
Last updated
4 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Super Cereal Plus (SC+), Super Cereal (SC), fortified oil, sugar and Plumpy Sup in people with Moderate Acute Malnutrition (MAM), run by Tufts University.

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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 4 Feb 2015. 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 was stopped early (reason given: Due to Ebola virus disease outbreak). Results are not available in the source record.

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 MAM (time frame: 12 weeks). 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 NCT02077907.

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 Feb 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in