Child Nutrition DisordersNCT01097889
Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition
A study testing Fortified blended foods, Corn Soya Bean Flour (CSB) with oil. and RUSF (ready-to-use supplementary foods) Supplementary Plumpy® in people with Child Nutrition Disorders, run by The Hospital for Sick Children at 2 sites in 2 countries.
Trial summary
Supplementary feeding programs for children with moderate acute malnutrition have been implemented in developing countries using treatment foods with minimal or no evidence of their effectiveness. Fortified peanut paste is a popular new treatment food for children with severe and moderate malnutrition. Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Child Nutrition Disorders
- What is being tested?
- Fortified blended foods, Corn Soya Bean Flour (CSB) with oil. and RUSF (ready-to-use supplementary foods) Supplementary Plumpy®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2009to Jul 2010
- 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 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children 6 to 60 months of age who are identified as malnourished based on MUAC measurements with WFH ≥70 to <80%.
Who cannot join
- Children with WFH < 70% or presenting with bilateral pitting oedema (they will be referred to therapeutic feeding programme).
- Children with any illness or clinical condition that prevents them from safely ingesting either supplementary foods. A child is medically assessed upon admission for any complicated clinical condition (oedema, malaria, vomiting, chronic diarrhea, infections, appetite, etc) that would require medical care and those children will be referred to the therapeutic feeding programme.
- All children transferred from the therapeutic feeding programme directly into the supplementary feeding programme - however they will not be included in the research study.
- Children with WFH > 80% but MUAC 110 to 120 mm- they will be admitted to SFP however will not be included in the research study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Ethiopia1 site
Regional Health Board - Health Posts in South Nations and Nationalities Peoples Region (SNNPR
Sidama Zone, Southern Ethiopia
About this study
Official title: Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition in Children 6-60 Months of Age in Southern Ethiopia
Supplementary feeding programs for children with moderate acute malnutrition have been implemented in developing countries using treatment foods with minimal or no evidence of their effectiveness. Fortified peanut paste is a popular new treatment food for children with severe and moderate malnutrition.
Objectives: To investigate the relative effectiveness of two non-identical therapeutic foods in children with moderate malnutrition by comparing differences in performance indicators (i.e. recovery rates), recovery times, and change in weight-for-height z-scores in each group.
This proposed research project will evaluate the relative effectiveness of two non-identical treatment foods for the treatment of moderate acute malnutrition in children
Read the detailed description
This research protocol will be embedded as a component of the UN World Food Programme (WFP) -supported Supplementary Feeding programmes in Ethiopia. The proposed study is a prospective cluster-randomized equivalence trial that will compare the relative effectiveness of two feeding interventions in four woredas (districts). Research will be implemented in two comparable woredas (one with CSB and one with RUSF), in two different areas in Sidama zone that represent different livelihood zones, main source of crop income, and level of food insecurity
- Conditions
- Child Nutrition Disorders
- Being tested
- Fortified blended foods, Corn Soya Bean Flour (CSB) with oil., RUSF (ready-to-use supplementary foods) Supplementary Plumpy®
- Keywords
- United Nations World Food Programme, blended food (CSB), ready-to-use supplementary foods (RUSF), Plumpy®
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.Dietary supplement
A daily ration equivalent of 300g CSB and 32g vegetable oil Bi-weekly distribution of premix of 4.2kg CSB with 0.5L vegetable oil. Estimated 1413 kcal, 47g protein
RUSF (ready-to-use supplementary foods) Supplementary Plumpy®Dietary supplement
Peanut-based fortified supplement
One 92g sachet eaten throughout the day Bi-weekly distributions of 14 sachets 500 kcal and 13g protein
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Active comparator | Not described Receives: Dietary Supplement: Fortified blended foods, Corn Soya Bean Flour (CSB) with oil. |
| Treatment Group 2 | Experimental | Not described Receives: Dietary Supplement: RUSF (ready-to-use supplementary foods) Supplementary Plumpy® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Analysis
Recovery rates in children from malnutrition
Measured: Baseline and at 16 Weeks
Secondary outcomes (2)
Anthropometrics Changes
Height, weight and middle upper arm circumference (MUAC)
Measured: Baseline, Weeks 2,4,6,8,10,12,14,16
Household Practices Questionnaire
Measured: At 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- 2,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Zlotkin, The Hospital for Sick Children
- Investigators
- Stanley Zlotkin, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097889
- Sponsor's protocol ID
- 1000013545
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2010
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Karakochuk C, van den Briel T, Stephens D, Zlotkin S. Treatment of moderate acute malnutrition with ready-to-use supplementary food results in higher overall recovery rates compared with a corn-soya blend in children in southern Ethiopia: an operations research trial. Am J Clin Nutr. 2012 Oct;96(4):911-6. doi: 10.3945/ajcn.111.029744. Epub 2012 Sep 5.
PubMed 22952175
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition in Children 6-60 Months of Age in Southern Ethiopia
- ClinicalTrials.gov ID
- NCT01097889
- Acronym / sponsor ID
- 1000013545
- Conditions
- Child Nutrition Disorders
- Keywords
- United Nations World Food Programme, blended food (CSB), ready-to-use supplementary foods (RUSF), Plumpy®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,600 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2009 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Apr 2010 (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.
Supplementary feeding programs for children with moderate acute malnutrition have been implemented in developing countries using treatment foods with minimal or no evidence of their effectiveness. Fortified peanut paste is a popular new treatment food for children with severe and moderate malnutrition.
Objectives: To investigate the relative effectiveness of two non-identical therapeutic foods in children with moderate malnutrition by comparing differences in performance indicators (i.e. recovery rates), recovery times, and change in weight-for-height z-scores in each group.
This proposed research project will evaluate the relative effectiveness of two non-identical treatment foods for the treatment of moderate acute malnutrition in children
Detailed description
This research protocol will be embedded as a component of the UN World Food Programme (WFP) -supported Supplementary Feeding programmes in Ethiopia. The proposed study is a prospective cluster-randomized equivalence trial that will compare the relative effectiveness of two feeding interventions in four woredas (districts). Research will be implemented in two comparable woredas (one with CSB and one with RUSF), in two different areas in Sidama zone that represent different livelihood zones, main source of crop income, and level of food insecurity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Active comparator | Dietary Supplement: Fortified blended foods, Corn Soya Bean Flour (CSB) with oil. |
| Treatment Group 2 | Experimental | Dietary Supplement: RUSF (ready-to-use supplementary foods) Supplementary Plumpy® |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children 6 to 60 months of age who are identified as malnourished based on MUAC measurements with WFH ≥70 to <80%.
Key exclusion criteria (4 listed)
- Children with WFH < 70% or presenting with bilateral pitting oedema (they will be referred to therapeutic feeding programme).
- Children with any illness or clinical condition that prevents them from safely ingesting either supplementary foods. A child is medically assessed upon admission for any complicated clinical condition (oedema, malaria, vomiting, chronic diarrhea, infections, appetite, etc) that would require medical care and those children will be referred to the therapeutic feeding programme.
- All children transferred from the therapeutic feeding programme directly into the supplementary feeding programme - however they will not be included in the research study.
- Children with WFH > 80% but MUAC 110 to 120 mm- they will be admitted to SFP however will not be included in the research study.
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 |
|---|---|---|
| Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.A daily ration equivalent of 300g CSB and 32g vegetable oil Bi-weekly distribution of premix of 4.2kg CSB with 0.5L vegetable oil. Estimated 1413 kcal, 47g protein | Dietary supplement | Treatment Group 1 |
| RUSF (ready-to-use supplementary foods) Supplementary Plumpy®Peanut-based fortified supplement One 92g sachet eaten throughout the day Bi-weekly distributions of 14 sachets 500 kcal and 13g protein | Dietary supplement | Treatment Group 2 |
Primary outcome
Survival Analysis
Time frame: Baseline and at 16 Weeks
Recovery rates in children from malnutrition
2 secondary outcomes
Anthropometrics Changes
Time frame: Baseline, Weeks 2,4,6,8,10,12,14,16
Household Practices Questionnaire
Time frame: At 16 weeks
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 19 Apr 2021.
- Derived from this study: PubMed 22952175Karakochuk C, van den Briel T, Stephens D, Zlotkin S. Treatment of moderate acute malnutrition with ready-to-use supplementary food results in higher overall recovery rates compared with a corn-soya blend in children in southern Ethiopia: an operations research trial. Am J Clin Nutr. 2012 Oct;96(4):911-6. doi: 10.3945/ajcn.111.029744. Epub 2012 Sep 5.
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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.
Stanley Zlotkin, MD principal investigator
The Hospital for Sick Children
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified blended foods, Corn Soya Bean Flour (CSB) with oil. and RUSF (ready-to-use supplementary foods) Supplementary Plumpy® in people with Child Nutrition Disorders, run by The Hospital for Sick Children at 2 sites in 2 countries.
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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Ethiopia. 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?
Survival Analysis (time frame: Baseline and at 16 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 NCT01097889, 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 19 Apr 2021.