Malnutrition Clinical Trial
— SNAC'SOfficial title:
Effectiveness and Acceptability of Nutritional Rehabilitation Based on Ready-to-use Food in HIV-infected Children and Adolescents in Senegal: The Multicentre SNAC'S Study
NCT number | NCT03101852 |
Other study ID # | 14SANIN203 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | September 2017 |
Verified date | March 2020 |
Source | Institut de Recherche pour le Developpement |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Severe (SAM, Body Mass Index-z < -3) and moderate (MAM, -3 ≤ BMI-z < -2) acute malnutrition, highly prevalent in HIV-infected children and adolescents, is an independent risk factor of death, even when antiretroviral treatment (ART) is initiated. The objectives of the SNAC'S study are to assess acceptability and effectiveness of outpatient nutritional rehabilitation, using ready-to-use food (RUF), elaborated in compliance with national and international recommendations and implemented in HIV-infected children and adolescents, under active follow-up in the 12 main pediatric HIV care sites in Senegal and presenting with SAM or MAM.
Status | Completed |
Enrollment | 185 |
Est. completion date | September 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility |
Inclusion Criteria: - infected with HIV - presenting with severe or moderate acute malnutrition - followed-up in one of the 12 study sites - written consent of the parent/legal guardian - verbal assent of the child Exclusion Criteria: - pregnancy - physical and/or mental disability incompatible with the study follow-up - living far from the study site (about more than 50km) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Institut de Recherche pour le Developpement | Global Fund, Sidaction, UNICEF, United Nations World Food Programme (WFP) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful nutritional rehabilitation | the child reach his/her target weight defined as weight-for-height >= - 2 z-scores in children < 5years; body mass index for age >= -2 z-score in children >= 5 years | up to 12 months | |
Secondary | long-term effectiveness | the child maintains stable weight (or gains weight) 3 months after reaching target weight. | 3 months | |
Secondary | long-term effectiveness | the child maintains stable weight (or gains weight) 6 months after reaching target weight. | 6 months |
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