A trial of different nutritional supplements and subsequent support to secure and sustain the recovery of moderately undernourished young children recovering from an illness
- Conditions
- Moderate wasting in children 6-24 months of ageNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN53213318
- Lead Sponsor
- World Health Organisation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 6360
1. Age 6-24 months
2. Moderately wasted i.e. WLZ =-2 and > -3 or MUAC <125 mm and >115 mm
3. Presenting with any of the following acute illnesses at a facility out-patient clinic or discharged from hospital after <7 days for any of the following:
3.1. Diarrhea, defined as three or more loose or watery stools (with or without blood) in the previous 24 hours, and no dehydration on assessment. If the child has dehydration, the dehydration will be treated re-assessing for recruitment, or
3.2. Pneumonia, defined as the presence before of fast breathing or chest indrawing, or
3.3. Non-malarial fever, defined as reported or measured (=38?C) fever of >3 days but <7 days duration
[Acute illness in the context of this trial: Children with significant acute illness are at higher risk for severe outcomes like risk of developing SAM or hospitalization/death. Decreasing the risk in these children is important. Therefore, acute illness in this trial will be defined as diarrhea, signs of pneumonia, malaria or fever. If fever, then this should be present for >3 days duration. Milder illnesses, for example, skin or common cold/ cough will not be considered as significant acute illness as having these mild illnesses are less likely to cause children to enter a downward spiral of increased risk of morbidity/mortality]
3.4. malaria, defined as reported or measured (=38?C) fever and positive rapid diagnostic test, or
4. Consent for study participation from parent or legal guardian
Current exclusion criteria as of 28/03/2024:
1. Severe acute malnutrition (WLZ <-3 or MUAC <115 mm or oedema of both feet)
2. General danger signs (lethargic/unconscious, convulsions, unable to drink, vomits everything)
3. Severe illness (severe pneumonia or very severe disease, severe dehydration, neck stiffness)
4. Persistent diarrhoea (=14 days)
5. Chronic infections/illness or disability, e.g. TB, HIV, congenital defects, cerebral palsy
6. Require hospital admission
7. Well child attended clinic only for routine growth monitoring or immunization
8. Child receiving food supplements for moderate wasting
9. Treated for moderate wasting in the previous 3 months
10. Previously enrolled in the study
11. Child with any known history of food allergy or food intolerance
12. Another child in the same household already recruited into the study
13. Child lives outside the study area routinely or will be outside of the study area for more than two weeks in the upcoming 3 months.
_____
Previous exclusion criteria:
1. Severe acute malnutrition (WLZ <-3 or MUAC <115 mm or oedema of both feet)
2. General danger signs (lethargic/unconscious, convulsions, unable to drink, vomits everything)
3. Severe illness (severe pneumonia or very severe disease, severe dehydration, neck stiffness)
4. Persistent diarrhoea (=14 days)
5. Chronic infections/illness or disability, e.g. TB, HIV, congenital defects, cerebral palsy
6. Require hospital admission
7. Well child attended clinic only for routine growth monitoring or immunization
8. Child receiving food supplements for moderate wasting
9. Treated for moderate wasting in the previous 3 months
10. Previously enrolled in the study
11. Child with any known history of food allergy or food intolerance
12. Another child in the same household already recruited into the study
13. Child lives outside the study area
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1: Anthropometric recovery at week 12 (defined as recovery from moderate wasting on weight-for-length z score [WLZ] or mid upper arm circumference [MUAC])<br>Phase 2: Anthropometric recovery at week 24 (defined as recovery from moderate wasting on weight-for-length z score or mid upper arm circumference)<br><br>Recovery is defined as WLZ >-2.0 or MUAC =125 mm (depending on whether the child was ascertained to have moderate wasting at enrolment based on a WLZ <-2 or a MUAC <125 mm or both. The child must show improvement on the parameter (WLZ >-2.0 or MUAC =125 mm) that indicated moderate wasting at enrolment. If the child was moderately wasted on both parameters, improvement on any one as defined above is accepted as recovery.
- Secondary Outcome Measures
Name Time Method