Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children (MODMAL)
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Purpose
The purpose of this study is to determine whether an outpatient-based strategy of short-term, ready to use supplementary food (RUSF) among moderately malnourished children with acute infections achieves greater improvement in anthropometric measurements of wasting than usual diet.
| Condition | Intervention |
|---|---|
|
Malnutrition Infection |
Dietary Supplement: Ready to Use Supplementary Food (RUSF) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial of an Outpatient Strategy of Ready to Use Supplementary Food (RUSF) Among Moderately Malnourished Children With Acute Infection |
- Change in WHZ-score [ Time Frame: between enrolment and 4 weeks ] [ Designated as safety issue: No ]
- Change in WHZ score [ Time Frame: between enrolment and 3 months ] [ Designated as safety issue: No ]
- Changes in MUAC [ Time Frame: between enrolment and 4 weeks and at 3 months ] [ Designated as safety issue: No ]
- Development of severe malnutrition (WHZ score <-3 and/or kwashiorkor) [ Time Frame: at 4 weeks and 3 months ] [ Designated as safety issue: No ]
- Anemia (Hb <10g/dl) [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
- Hospital admission or death [ Time Frame: during study period and in the subsequent year ] [ Designated as safety issue: No ]
- Differences in levels of immune activation and inflammatory markers [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | May 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
RUSF prescribed for the child for 4 weeks
|
Dietary Supplement: Ready to Use Supplementary Food (RUSF)
It is a strategy of detection of moderate malnutrition and providing advice and short term provision of a standard formulation of ready to use supplementary food (RUSF) for 4 weeks with appropriate counseling on its use.The amount supplied will be based on the child's weight; 100kcal per kg per day which is equivalent to 25g RUSF per kg per day.
Other Name: RUSF
|
|
No Intervention: 2
normal diet
|
Detailed Description:
Under nutrition is a contributing factor to at least a third of child deaths. Whilst severe malnutrition has the highest mortality risk, most malnutrition-related deaths are thought to be related to mild-moderate malnutrition.This is because moderate malnutrition is common, it directly increases the risk of death from common infectious diseases and may progress to severe malnutrition.
Malnutrition may arise from poverty, food insecurity or inadequate nutrition being offered, and may begin early in life. Malnutrition is exacerbated by the multiple effects of infectious diseases such as gastroenteritis, pneumonia, malaria or HIV. All these common infections are associated with net protein loss with diversion of essential amino acids to producing acute phase and immune response proteins. Fever is associated with an increased resting energy expenditure of 7 to 13% per degree Centigrade. Activation of inflammatory cascades also causes reduced appetite and loss of lean tissue and fat. Acute infection is therefore associated with growth faltering, resulting in a vicious cycle. Acute infection is therefore a potential target for intervention to interrupt the vicious cycle between malnutrition and infection in children.
This study aims to evaluate a strategy of giving short-term RUSF as a supplement to usual diet at home, without daily observed feeding, administered through existing health services at Kilifi District Hospital, Kenya. RUSF has a very low moisture content and is essentially a lipid-enveloped paste, it is microbiologically stable with a long shelf life at tropical temperatures and preserves delicate micronutrients such as vitamin A.
Eligibility| Ages Eligible for Study: | 6 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 6 months to 5 years
- Mid-upper arm circumference (MUAC) less than 12.5 cm
- Resident in the Kilifi demographic surveillance (DSS) area
- Presentation with acute (<5 days) illness including respiratory infection, malaria, diarrhoeal disease or other acute infection.
- If admitted, admission of <5 days, recruited at discharge.
Exclusion Criteria:
- Severe malnutrition (WHZ score < -3 or Kwashiorkor)
- Requiring admission to hospital in the opinion of clinician
- Known allergy to maize, soya, sorghum, milk or any RUSF components.
- Consent declined
- Underlying condition precluding assessment or inclusion
- Any other reason why the consenting investigator thinks it is not appropriate for them to take part.
Contacts and Locations| Kenya | |
| Kemri Wellcome Trust Research Programme | |
| Kilifi, Coast Province, Kenya, 80108 | |
| Kilifi District Hospital- OPD | |
| Kilifi, Coast, Kenya, 80108 | |
| Principal Investigator: | James A Berkley | KEMRI-Wellcome Trust Collaborative Research Program |
More Information
No publications provided
| Responsible Party: | Dr James Berkley, KEMRI Wellcome Trust Research Programme |
| ClinicalTrials.gov Identifier: | NCT00890695 History of Changes |
| Other Study ID Numbers: | SSC 1415 |
| Study First Received: | April 29, 2009 |
| Last Updated: | June 13, 2011 |
| Health Authority: | Kenya: Ethical Review Committee |
Keywords provided by University of Oxford:
|
supplementary feeding moderate malnutrition acute infection developing country children |
Additional relevant MeSH terms:
|
Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on June 13, 2013