Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soy/peanut fortified spread | Active Comparator |
| |
| Milk fortified corn/soy blend | Experimental |
| |
| Supplementary Plumpy® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soy/peanut fortified spread | Dietary Supplement | 75kcal/kg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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/ | 12 weeks or upon completion of recovery |
| Number of Patients With Absence of Bilateral Pedal Pitting Edema | 12 weeks or recovery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Number of Patients With Adverse Outcomes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark J Manary, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malawi College of Medicine | Blantyre | 03 | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25419681 | Derived | 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. | |
| 23256140 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Milk Fortified Corn/Soy Blend | Milk fortified corn/soy blend : 75 kcal/kg/day |
| FG001 | Soy/Peanut Fortified Spread | Soy/peanut fortified spread : 75kcal/kg/day |
| FG002 | Supplementary Plumpy® | Supplementary Plumpy® : 75 kcal/kg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Milk Fortified Corn/Soy Blend | Milk fortified corn/soy blend : 75 kcal/kg/day |
| BG001 | Soy/Peanut Fortified Spread | Soy/peanut fortified spread : 75kcal/kg/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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/ | Posted | Number | participants | 12 weeks or upon completion of recovery |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Milk Fortified Corn/Soy Blend | Milk fortified corn/soy blend : 75 kcal/kg/day |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Indi Trehan | Washington University in St. Louis | 5039284634 | itrehan@wustl.edu |
Not provided
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Milk fortified corn/soy blend |
| Dietary Supplement |
75 kcal/kg/day |
|
| Supplementary Plumpy® | Dietary Supplement | 75 kcal/kg/day |
|
This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.
| 12 months |
| Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment | 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. | 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 | 4 weeks |
| Chang 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. |
| 22170366 | Derived | LaGrone 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. |
| BG002 | Supplementary Plumpy® | Supplementary Plumpy® : 75 kcal/kg/day |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Supplementary Plumpy® : 75 kcal/kg/day |
|
|
| Primary | Number of Patients With Absence of Bilateral Pedal Pitting Edema | Posted | Number | participants | 12 weeks or recovery |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | g/kg/d | 4 weeks |
|
|
|
| Secondary | Number of Patients With Adverse Outcomes | This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment | Posted | Number | participants | 2 weeks |
|
|
|
| Secondary | 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. | Children who successfully recovered from MAM following the standard treat-to-WHZ -2 protocol. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | mm/d | 4 weeks |
|
|
|
| 0 |
| 888 |
| 0 |
| 888 |
| EG001 | Soy/Peanut Fortified Spread | Soy/peanut fortified spread : 75kcal/kg/day | 0 | 906 | 0 | 906 |
| EG002 | Supplementary Plumpy® | Supplementary Plumpy® : 75 kcal/kg/day | 0 | 918 | 0 | 918 |
Not provided
Not provided
Not provided
|
| Title | Measurements |
|---|---|
|
| developed marasmus |
|
| developed kwashiorkor |
|
| died |
|
| lost to follow-up |
|
|