Malnutrition
Conditions
Keywords
Malnutrition, Supplemental Food, CSB++, Supplementary Plumpy
Brief 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.
Interventions
DIETARY_SUPPLEMENTSoy/peanut fortified spread
75kcal/kg/day
DIETARY_SUPPLEMENTMilk fortified corn/soy blend
75 kcal/kg/day
DIETARY_SUPPLEMENTSupplementary Plumpy®
75 kcal/kg/day
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* WHZ \<-2 but \>-3 without bilateral pedal edema * Reside within 7 kilometers of study site.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Nutritional Recovery | 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 | 12 weeks or recovery | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment | 2 weeks | — |
| Rate of Weight Gain | 4 weeks | 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 |
| Rates of Gain in Mid-upper Arm Circumference, and Length | 4 weeks | 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 |
| Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | 12 months | 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. |
| Number of Patients With Adverse Outcomes | 12 months | This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food. |
Countries
Malawi
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Milk Fortified Corn/Soy Blend Milk fortified corn/soy blend : 75 kcal/kg/day | 888 |
| Soy/Peanut Fortified Spread Soy/peanut fortified spread : 75kcal/kg/day | 906 |
| Supplementary Plumpy® Supplementary Plumpy® : 75 kcal/kg/day | 918 |
| Total | 2,712 |
Baseline characteristics
| Characteristic | Soy/Peanut Fortified Spread | Supplementary Plumpy® | Milk Fortified Corn/Soy Blend | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 906 Participants | 918 Participants | 888 Participants | 2712 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.63 years STANDARD_DEVIATION 0.9 | 1.61 years STANDARD_DEVIATION 0.92 | 1.63 years STANDARD_DEVIATION 0.92 | 1.62 years STANDARD_DEVIATION 0.91 |
| Region of Enrollment Malawi | 906 participants | 918 participants | 888 participants | 2712 participants |
| Sex: Female, Male Female | 562 Participants | 583 Participants | 539 Participants | 1684 Participants |
| Sex: Female, Male Male | 344 Participants | 335 Participants | 349 Participants | 1028 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 888 | 0 / 906 | 0 / 918 |
| serious Total, serious adverse events | 0 / 888 | 0 / 906 | 0 / 918 |
Outcome results
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/
Time frame: 12 weeks or upon completion of recovery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Milk Fortified Corn/Soy Blend | Number of Participants With Nutritional Recovery | 763 participants |
| Soy/Peanut Fortified Spread | Number of Participants With Nutritional Recovery | 795 participants |
| Supplementary Plumpy® | Number of Participants With Nutritional Recovery | 807 participants |
Primary
Number of Patients With Absence of Bilateral Pedal Pitting Edema
Time frame: 12 weeks or recovery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Milk Fortified Corn/Soy Blend | Number of Patients With Absence of Bilateral Pedal Pitting Edema | 850 participants |
| Soy/Peanut Fortified Spread | Number of Patients With Absence of Bilateral Pedal Pitting Edema | 871 participants |
| Supplementary Plumpy® | Number of Patients With Absence of Bilateral Pedal Pitting Edema | 879 participants |
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Milk Fortified Corn/Soy Blend | Number of Patients With Adverse Outcomes | 0 participants |
| Soy/Peanut Fortified Spread | Number of Patients With Adverse Outcomes | 0 participants |
| Supplementary Plumpy® | Number of Patients With Adverse Outcomes | 0 participants |
Secondary
Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Milk Fortified Corn/Soy Blend | Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment | diarrhea during first 2 weeks | 271 participants |
| Milk Fortified Corn/Soy Blend | Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment | vomiting during first 2 weeks | 89 participants |
| Soy/Peanut Fortified Spread | Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment | diarrhea during first 2 weeks | 303 participants |
| Soy/Peanut Fortified Spread | Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment | vomiting during first 2 weeks | 127 participants |
| Supplementary Plumpy® | Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment | diarrhea during first 2 weeks | 309 participants |
| Supplementary Plumpy® | Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment | vomiting during first 2 weeks | 124 participants |
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
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Milk Fortified Corn/Soy Blend | Rate of Weight Gain | 3.1 g/kg/d | Standard Deviation 2.4 |
| Soy/Peanut Fortified Spread | Rate of Weight Gain | 3.4 g/kg/d | Standard Deviation 2.6 |
| Supplementary Plumpy® | Rate of Weight Gain | 3.6 g/kg/d | Standard Deviation 2.8 |
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
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Milk Fortified Corn/Soy Blend | Rates of Gain in Mid-upper Arm Circumference, and Length | MUAC gain (mm/d) | 0.13 mm/d | Standard Deviation 0.4 |
| Milk Fortified Corn/Soy Blend | Rates of Gain in Mid-upper Arm Circumference, and Length | length gain (mm/d) | 0.13 mm/d | Standard Deviation 0.46 |
| Soy/Peanut Fortified Spread | Rates of Gain in Mid-upper Arm Circumference, and Length | MUAC gain (mm/d) | 0.13 mm/d | Standard Deviation 0.43 |
| Soy/Peanut Fortified Spread | Rates of Gain in Mid-upper Arm Circumference, and Length | length gain (mm/d) | 0.13 mm/d | Standard Deviation 0.44 |
| Supplementary Plumpy® | Rates of Gain in Mid-upper Arm Circumference, and Length | MUAC gain (mm/d) | 0.21 mm/d | Standard Deviation 0.44 |
| Supplementary Plumpy® | Rates of Gain in Mid-upper Arm Circumference, and Length | length gain (mm/d) | 0.15 mm/d | Standard Deviation 0.47 |
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.
Time frame: 12 months
Population: Children who successfully recovered from MAM following the standard treat-to-WHZ -2 protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Milk Fortified Corn/Soy Blend | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | well-nourished | 402 participants |
| Milk Fortified Corn/Soy Blend | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | relapsed into MAM | 110 participants |
| Milk Fortified Corn/Soy Blend | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | developed marasmus | 35 participants |
| Milk Fortified Corn/Soy Blend | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | developed kwashiorkor | 28 participants |
| Milk Fortified Corn/Soy Blend | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | died | 32 participants |
| Milk Fortified Corn/Soy Blend | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | lost to follow-up | 46 participants |
| Soy/Peanut Fortified Spread | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | lost to follow-up | 54 participants |
| Soy/Peanut Fortified Spread | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | well-nourished | 382 participants |
| Soy/Peanut Fortified Spread | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | developed kwashiorkor | 47 participants |
| Soy/Peanut Fortified Spread | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | died | 19 participants |
| Soy/Peanut Fortified Spread | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | relapsed into MAM | 117 participants |
| Soy/Peanut Fortified Spread | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | developed marasmus | 28 participants |
| Supplementary Plumpy® | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | relapsed into MAM | 107 participants |
| Supplementary Plumpy® | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | developed marasmus | 20 participants |
| Supplementary Plumpy® | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | lost to follow-up | 39 participants |
| Supplementary Plumpy® | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | developed kwashiorkor | 32 participants |
| Supplementary Plumpy® | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | well-nourished | 446 participants |
| Supplementary Plumpy® | Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | died | 23 participants |