MalnutritionNCT00998517
Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition
A study testing Soy/peanut fortified spread, Milk fortified corn/soy blend and Supplementary Plumpy® in people with Malnutrition, run by Washington University School of Medicine at 1 site in Malawi.
Trial summary
The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malnutrition
- What is being tested?
- Soy/peanut fortified spread, Milk fortified corn/soy blend and Supplementary Plumpy®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,712 participants
- Where
- 1 siteMalawi
- Study dates
- Oct 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- WHZ <-2 but >-3 without bilateral pedal edema
- Reside within 7 kilometers of study site.
Who cannot join
- Not permanent resident in vicinity of study site.
- Severe chronic illness such as cerebral palsy.
- History of peanut allergy or anaphylaxis resulting from any food.
- Receiving other supplementary food or participating in other research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Novel Fortified Blended Flour to Ready-to-use Supplemental Foods for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomized, Investigator-blinded, Clinical Effectiveness Trial
The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.
- Conditions
- Malnutrition
- Being tested
- Soy/peanut fortified spread, Milk fortified corn/soy blend, Supplementary Plumpy®
- Keywords
- Malnutrition, Supplemental Food, CSB++, Supplementary Plumpy
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy/peanut fortified spreadDietary supplement
75kcal/kg/day
Milk fortified corn/soy blendDietary supplement
75 kcal/kg/day
Supplementary Plumpy®Dietary supplement
75 kcal/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Soy/peanut fortified spread | Active comparator | Not described Receives: Dietary Supplement: Soy/peanut fortified spread |
| Milk fortified corn/soy blend | Experimental | Not described Receives: Dietary Supplement: Milk fortified corn/soy blend |
| Supplementary Plumpy® | Active comparator | Not described Receives: Dietary Supplement: Supplementary Plumpy® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Nutritional Recovery
Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length.
WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/
Measured: 12 weeks or upon completion of recovery
Number of Patients With Absence of Bilateral Pedal Pitting Edema
Measured: 12 weeks or recovery
Secondary outcomes (5)
Rate of Weight Gain
This rate will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks
Measured: 4 weeks
Number of Patients With Adverse Outcomes
This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.
Measured: 12 months
Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment
Measured: 2 weeks
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)
Children who were successfully treated for MAM in the primary portion of the study were followed prospectively with scheduled follow-up visits for 12 months to evaluate whether they remained well-nourished, defined as mid-upper arm circumference (MUAC) >= 12.5 cm or weight-for-height Z-score >= -2 throughout the duration of follow-up.
Measured: 12 months
Rates of Gain in Mid-upper Arm Circumference, and Length
These rates will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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
- 2,712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998517
- Sponsor's protocol ID
- SOYA2009
- Status last verified
- Apr 2014
- First submitted
- 19 Oct 2009
- Last updated
- 12 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Trehan I, Banerjee S, Murray E, Ryan KN, Thakwalakwa C, Maleta KM, Manary MJ. Extending supplementary feeding for children younger than 5 years with moderate acute malnutrition leads to lower relapse rates. J Pediatr Gastroenterol Nutr. 2015 Apr;60(4):544-9. doi: 10.1097/MPG.0000000000000639.
PubMed 25419681Chang 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 23256140LaGrone LN, Trehan I, Meuli GJ, Wang RJ, Thakwalakwa C, Maleta K, Manary MJ. A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children. Am J Clin Nutr. 2012 Jan;95(1):212-9. doi: 10.3945/ajcn.111.022525. Epub 2011 Dec 14.
PubMed 22170366
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel Fortified Blended Flour to Ready-to-use Supplemental Foods for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomized, Investigator-blinded, Clinical Effectiveness Trial
- ClinicalTrials.gov ID
- NCT00998517
- Acronym / sponsor ID
- SOYA2009
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Supplemental Food, CSB++, Supplementary Plumpy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,712 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Posted 12 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soy/peanut fortified spread | Active comparator | Dietary Supplement: Soy/peanut fortified spread |
| Milk fortified corn/soy blend | Experimental | Dietary Supplement: Milk fortified corn/soy blend |
| Supplementary Plumpy® | Active comparator | Dietary Supplement: Supplementary Plumpy® |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- WHZ <-2 but >-3 without bilateral pedal edema
- Reside within 7 kilometers of study site.
Key exclusion criteria (4 listed)
- Not permanent resident in vicinity of study site.
- Severe chronic illness such as cerebral palsy.
- History of peanut allergy or anaphylaxis resulting from any food.
- 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 |
|---|---|---|
| Soy/peanut fortified spread75kcal/kg/day | Dietary supplement | Soy/peanut fortified spread |
| Milk fortified corn/soy blend75 kcal/kg/day | Dietary supplement | Milk fortified corn/soy blend |
| Supplementary Plumpy®75 kcal/kg/day | Dietary supplement | Supplementary Plumpy® |
Primary outcome
Number of Participants With Nutritional Recovery
Time frame: 12 weeks or upon completion of recovery
Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length. WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/
Number of Patients With Absence of Bilateral Pedal Pitting Edema
Time frame: 12 weeks or recovery
5 secondary outcomes
Rate of Weight Gain
Time frame: 4 weeks
Number of Patients With Adverse Outcomes
Time frame: 12 months
Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment
Time frame: 2 weeks
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)
Time frame: 12 months
Rates of Gain in Mid-upper Arm Circumference, and Length
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25419681Trehan I, Banerjee S, Murray E, Ryan KN, Thakwalakwa C, Maleta KM, Manary MJ. Extending supplementary feeding for children younger than 5 years with moderate acute malnutrition leads to lower relapse rates. J Pediatr Gastroenterol Nutr. 2015 Apr;60(4):544-9. doi: 10.1097/MPG.0000000000000639.
- Derived from this study: 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.
- Derived from this study: PubMed 22170366LaGrone LN, Trehan I, Meuli GJ, Wang RJ, Thakwalakwa C, Maleta K, Manary MJ. A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children. Am J Clin Nutr. 2012 Jan;95(1):212-9. doi: 10.3945/ajcn.111.022525. Epub 2011 Dec 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, M.D. 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 Soy/peanut fortified spread, Milk fortified corn/soy blend and Supplementary Plumpy® 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 2 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 12 May 2014. 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?
Yes. Results are posted in the registry (first posted 12 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Nutritional Recovery (time frame: 12 weeks or upon completion of recovery). The study lists 2 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 NCT00998517, which also lists 3 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 12 May 2014.