Trial Outcomes & Findings for Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition (NCT NCT00998517)

NCT ID: NCT00998517

Last Updated: 2014-05-12

Results Overview

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/

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2712 participants
• Primary outcome timeframe: 12 weeks or upon completion of recovery
• Results posted on: 2014-05-12

Participant Flow

Participant milestones

Measure	Milk Fortified Corn/Soy Blend Milk fortified corn/soy blend : 75 kcal/kg/day	Soy/Peanut Fortified Spread Soy/peanut fortified spread : 75kcal/kg/day	Supplementary Plumpy® Supplementary Plumpy® : 75 kcal/kg/day
Overall Study STARTED	888	906	918
Overall Study COMPLETED	888	906	918
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition

Baseline characteristics by cohort

Measure	Milk Fortified Corn/Soy Blend n=888 Participants Milk fortified corn/soy blend : 75 kcal/kg/day	Soy/Peanut Fortified Spread n=906 Participants Soy/peanut fortified spread : 75kcal/kg/day	Supplementary Plumpy® n=918 Participants Supplementary Plumpy® : 75 kcal/kg/day	Total n=2712 Participants Total of all reporting groups
Age, Categorical <=18 years	888 Participants n=5 Participants	906 Participants n=7 Participants	918 Participants n=5 Participants	2712 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	1.63 years STANDARD_DEVIATION 0.92 • n=5 Participants	1.63 years STANDARD_DEVIATION 0.9 • n=7 Participants	1.61 years STANDARD_DEVIATION 0.92 • n=5 Participants	1.62 years STANDARD_DEVIATION 0.91 • n=4 Participants
Sex: Female, Male Female	539 Participants n=5 Participants	562 Participants n=7 Participants	583 Participants n=5 Participants	1684 Participants n=4 Participants
Sex: Female, Male Male	349 Participants n=5 Participants	344 Participants n=7 Participants	335 Participants n=5 Participants	1028 Participants n=4 Participants
Region of Enrollment Malawi	888 participants n=5 Participants	906 participants n=7 Participants	918 participants n=5 Participants	2712 participants n=4 Participants

PRIMARY outcome

Timeframe: 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/

Outcome measures

Measure	Milk Fortified Corn/Soy Blend n=888 Participants Milk fortified corn/soy blend : 75 kcal/kg/day	Soy/Peanut Fortified Spread n=906 Participants Soy/peanut fortified spread : 75kcal/kg/day	Supplementary Plumpy® n=918 Participants Supplementary Plumpy® : 75 kcal/kg/day
Number of Participants With Nutritional Recovery	763 participants	795 participants	807 participants

PRIMARY outcome

Timeframe: 12 weeks or recovery

Outcome measures

Measure	Milk Fortified Corn/Soy Blend n=888 Participants Milk fortified corn/soy blend : 75 kcal/kg/day	Soy/Peanut Fortified Spread n=906 Participants Soy/peanut fortified spread : 75kcal/kg/day	Supplementary Plumpy® n=918 Participants Supplementary Plumpy® : 75 kcal/kg/day
Number of Patients With Absence of Bilateral Pedal Pitting Edema	850 participants	871 participants	879 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Milk Fortified Corn/Soy Blend n=888 Participants Milk fortified corn/soy blend : 75 kcal/kg/day	Soy/Peanut Fortified Spread n=906 Participants Soy/peanut fortified spread : 75kcal/kg/day	Supplementary Plumpy® n=918 Participants Supplementary Plumpy® : 75 kcal/kg/day
Rate of Weight Gain	3.1 g/kg/d Standard Deviation 2.4	3.4 g/kg/d Standard Deviation 2.6	3.6 g/kg/d Standard Deviation 2.8

SECONDARY outcome

Timeframe: 12 months

This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.

Outcome measures

Measure	Milk Fortified Corn/Soy Blend n=888 Participants Milk fortified corn/soy blend : 75 kcal/kg/day	Soy/Peanut Fortified Spread n=906 Participants Soy/peanut fortified spread : 75kcal/kg/day	Supplementary Plumpy® n=918 Participants Supplementary Plumpy® : 75 kcal/kg/day
Number of Patients With Adverse Outcomes	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Milk Fortified Corn/Soy Blend n=888 Participants Milk fortified corn/soy blend : 75 kcal/kg/day	Soy/Peanut Fortified Spread n=906 Participants Soy/peanut fortified spread : 75kcal/kg/day	Supplementary Plumpy® n=918 Participants Supplementary Plumpy® : 75 kcal/kg/day
Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment diarrhea during first 2 weeks	271 participants	303 participants	309 participants
Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment vomiting during first 2 weeks	89 participants	127 participants	124 participants

SECONDARY outcome

Timeframe: 12 months

Population: Children who successfully recovered from MAM following the standard treat-to-WHZ -2 protocol.

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.

Outcome measures

Measure	Milk Fortified Corn/Soy Blend n=653 Participants Milk fortified corn/soy blend : 75 kcal/kg/day	Soy/Peanut Fortified Spread n=647 Participants Soy/peanut fortified spread : 75kcal/kg/day	Supplementary Plumpy® n=667 Participants Supplementary Plumpy® : 75 kcal/kg/day
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) well-nourished	402 participants	382 participants	446 participants
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) relapsed into MAM	110 participants	117 participants	107 participants
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) developed marasmus	35 participants	28 participants	20 participants
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) developed kwashiorkor	28 participants	47 participants	32 participants
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) died	32 participants	19 participants	23 participants
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) lost to follow-up	46 participants	54 participants	39 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Milk Fortified Corn/Soy Blend n=888 Participants Milk fortified corn/soy blend : 75 kcal/kg/day	Soy/Peanut Fortified Spread n=906 Participants Soy/peanut fortified spread : 75kcal/kg/day	Supplementary Plumpy® n=918 Participants Supplementary Plumpy® : 75 kcal/kg/day
Rates of Gain in Mid-upper Arm Circumference, and Length MUAC gain (mm/d)	0.13 mm/d Standard Deviation 0.40	0.13 mm/d Standard Deviation 0.43	0.21 mm/d Standard Deviation 0.44
Rates of Gain in Mid-upper Arm Circumference, and Length length gain (mm/d)	0.13 mm/d Standard Deviation 0.46	0.13 mm/d Standard Deviation 0.44	0.15 mm/d Standard Deviation 0.47

Adverse Events

Milk Fortified Corn/Soy Blend

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Soy/Peanut Fortified Spread

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Supplementary Plumpy®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Indi Trehan

Washington University in St. Louis

Phone: 5039284634

Email: itrehan@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place