A comparison of diets to treat moderate childhood malnutrition
| ISRCTN | ISRCTN47598408 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47598408 |
| Protocol serial number | 2620-22-0-00-P-0089 |
| Sponsor | Academy for Educational Development (AED) (USA) |
| Funders | Academy for Educational Development (AED) (USA), Allen Foundation Inc. (USA) |
- Submission date
- 01/05/2008
- Registration date
- 12/05/2008
- Last edited
- 12/05/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Mark Manary
Scientific
Scientific
Department of Pediatrics
St. Louis Children's Hospital
One Children's Place
NWT 9109
St. Louis, MO
63110
United States of America
| manary@kids.wustl.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, investigator blinded clinical effectiveness trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised controlled trial comparing the impacts of feeding with milk/peanut ready-to-use therapeutic food (RUTF), soy/peanut RUTF, and corn-soy blend (CSB) among children with moderate acute malnutrition in Malawi |
| Study objectives | 12 - 60 month-old children with moderate acute malnutrition (weight-for-height z score [WHZ] greater than -3 and less than -2) whose caretakers are provided with supplements and counseling to feed the child with 75 kcal/kg/day of either milk/peanut ready-to-use therapeutic food (MP-RUTF) or soy/peanut ready-to-use therapeutic food (SP-RUTF) are more likely to recover from moderate acute malnutrition during an eight-week intervention than comparable children receiving isoenergetic rations of corn-soy blend (CSB); in addition among children receiving MP-RUTF or SP-RUTF, the recovery rate will not differ by more than 10%. |
| Ethics approval(s) | Ethics approval received from: 1. College of Medicine Research and Ethics Committee (Malawi) on the 17th July 2007 (ref: P.06/07/564) 2. Washington University Human Studies Committee on the 18th July 2007 (ref: 07-0642) |
| Health condition(s) or problem(s) studied | Moderate malnutrition |
| Intervention | Feeding with one of three foods: 1. Ready-to-use milk/peanut fortified spread 2. Ready-to-use soy/peanut fortified spread 3. Corn soy blend Children will receive isoenergetic amounts of one of the above three foods for up to eight weeks. The amount of food given is sufficient to provide 75 kcal/kg/d. The children will be followed biweekly, having weight, length, and mid-upper arm circumference measured; and the number of days of fever, cough and diarrhoea recorded from caretaker's report. Follow-up is for eight weeks. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Recovery, measured at the completion of the feeding period, usually eight weeks. |
| Key secondary outcome measure(s) |
1. Weight gain, measured after four weeks |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Months |
| Upper age limit | 60 Months |
| Sex | All |
| Target sample size at registration | 1400 |
| Key inclusion criteria | 1. Children aged 12 - 60 months 2. Moderate acute malnutrition using the World Health Organization (WHO) criteria (WHZ greater than -3 and less than -2) 3. Reside within 7 km 4. Present to one of seven supplementary feeding sites in southern Malawi during the study recruitment period |
| Key exclusion criteria | 1. Children who are not permanent residents in the vicinity of the local health centre (distance from home to health centre greater than 7 km) 2. Have severe chronic illnesses such as cerebral palsy 3. Have a history of peanut allergy or anaphylaxis resulting from any food 4. Receive other supplementary food from a government or charitable agency 5. Participating in another research study |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Malawi
- United States of America
Study participating centre
Department of Pediatrics
St. Louis, MO
63110
United States of America
63110
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
