Comparison of 10% milk ready-to-use food to 25% milk ready-to-use food in the treatment of severely malnourished, Malawian children
| ISRCTN | ISRCTN54186063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54186063 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/06/2009
- Registration date
- 04/06/2009
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Mary Manary
Scientific
Scientific
Washington University School of Medicine
One Children's Place
St. Louis
63110
United States of America
| Phone | +1 314 454 2178 |
|---|---|
| manary@kids.wustl.edu |
Study information
| Study design | Randomised double-blind controlled clinical effectiveness trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised, double-blind controlled clinical effectiveness trial comparing 10% milk ready-to-use food with 25% milk ready-to-use food (RUTF) in the treatment of severe acute malnutrition in rural Malawian children |
| Study objectives | The proposed study tests the hypothesis that 12 - 60 month-old children with severe acute malnutrition whose caretakers are provided with supplements and counselling to feed the child with 175 kcal/kg/d of either 10% milk ready-to-use therapeutic food (RUTF) or 25% milk RUTF are likely to recover at a similar rate during an 8-week intervention. |
| Ethics approval(s) | Washington University Human Research Protection Office approved on the 21st May 2008 (ref: FWA00002284; 08-0513) |
| Health condition(s) or problem(s) studied | Childhood severe acute malnutrition |
| Intervention | The randomised food product, 10% milk RUTF or 25% milk RUTF, sufficient for two weeks' feeding to the treated child will be given to the subject's caretaker with instructions on daily feeding methods and advice not to share the food product with other members of the household. Children and their caretakers will return for follow-up, food collection, and measurements and monitoring of the child's growth and any adverse events every 2 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ready-to-use therapeutic food (RUTF) |
| Primary outcome measure | Recovery, defined as weight-for-height z-score greater than -2 on two consecutive visits. |
| Secondary outcome measures | 1. Rates of gain in weight, height and mid-upper arm circumference 2. Adverse outcomes such as death 3. Number of days of fever, cough and diarrhoea Measured at each return visit, i.e. every two weeks until the child reached the final outcome of recovery/death/another outcome. |
| Overall study start date | 06/01/2008 |
| Completion date | 05/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Months |
| Upper age limit | 60 Months |
| Sex | Both |
| Target number of participants | 1800 |
| Total final enrolment | 1874 |
| Key inclusion criteria | 1. Children aged 12 - 60 months, either sex 2. Suffering from severe acute malnutrition 3. Reside within 7 kilometres of and present to one of the 15 feeding sites during the recruitment period |
| Key exclusion criteria | 1. Not permanent residents in the vicinity of one of the feeding sites 2. Severe chronic illness, e.g., cerebral palsy 3. A history of peanut allergy or anaphylaxis resulting from any food 4. Receiving other supplementary food 5. Participating in another research study |
| Date of first enrolment | 06/01/2008 |
| Date of final enrolment | 05/01/2009 |
Locations
Countries of recruitment
- Malawi
- United States of America
Study participating centre
Washington University School of Medicine
St. Louis
63110
United States of America
63110
United States of America
Sponsor information
University of Malawi College of Medicine (Malawi)
University/education
University/education
Private Bag 360
Blantyre
3
Malawi
| Website | http://www.medcol.mw/ |
|---|---|
"ROR" |
https://ror.org/04vtx5s55 |
Funders
Funder type
Charity
Hickey Family Foundation (USA) - Academy for Educational Development
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2010 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
