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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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14 January 2019 |
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Main ID: |
ISRCTN92405176 |
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Date of registration:
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15/05/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Does treatment for severe malnutrition make children who are short for their age overweight?
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Scientific title:
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Does treatment for severe acute malnutrition for children aged 6-59 months, identified by Mid-Upper Arm Circumference and that are less than 65 cm or have low height for age and treated with Ready to Use Therapeutic Food cause the child to become overweight or obese following cure? |
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Date of first enrolment:
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01/03/2011 |
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Target sample size:
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258 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN92405176 |
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Study type:
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Observational |
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Study design:
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Single-centre observational cross-sectional cohort study (Other)
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Phase:
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Countries of recruitment
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Malawi
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Paul
Binns |
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Address:
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Prestwich
M25
Manchester
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Aged 6 - 59 months
2. Mid upper arm circumference <11.5cm
3. Good appetite for ready-to-use therapeutic food
4. No medical complications requiring transfer to hospital
5. Consent from carer to participate
Exclusion criteria:
1. Aged <6 months or >59 months
2. MUAC >11.5cm
3. Anorexia
4. Any medical complication requiring transfer to hospital
5. Refusal of consent
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Overweight following treatment for severe acute malnutrition
Nutritional, Metabolic, Endocrine
Hyperalimentation
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Intervention(s)
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Children aged 6 to 59 months were enrolled in outpatient treatment for SAM if they had a MUAC less than 115 mm without medical complications irrespective of height on admission. 163 children were discharged as cured when a MUAC of 125 mm or greater was obtained for 2 consecutive clinic visits and the child was clinically well. MUAC, triceps skin fold (TSF) thickness and weight were measured at each visit and height was measured on admission and discharge.
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Primary Outcome(s)
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Weight for height z-score on discharge
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Secondary Outcome(s)
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1. Triceps skin fold for age z-score on discharge
2. Arm fat index for age z-score on discharge
3. Weight for age z score on discharge
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Secondary ID(s)
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4001-08-1-01/4001-VALID- 00/Task Order 4.
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Source(s) of Monetary Support
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FHI 360, Valid International
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Ethics review
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Status:
Approval date:
Contact:
National Health Sciences Research Committee of Malawi, 30/11/2010, Protocol #817 MED/4/36c
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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18/12/2013 |
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URL:
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