Nutritional Rehabilitation in Senegalese HIV-infected Children and Adolescents (SNAC'S)
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|ClinicalTrials.gov Identifier: NCT03101852|
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition HIV/AIDS||Dietary Supplement: Plumpy Nut Dietary Supplement: Plumpy Sup||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||185 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||September 2017|
Experimental: Nutritional therapy
Children included in the study with severe acute malnutrition receive Plumpy Nut: WHO recommends a Plumpy Nut® prescription of 75 to 100 kcal/kg/d in children aged 5 to 10 years and 60 to 90 kcal/kg/d above that age. The lowest value was used and maximum energy intake provided by RUF was limited to 2,000 kcal/d i.e. 4 sachets in order to preserve habitual diet and prevent appetite saturation
Dietary Supplement: Plumpy Nut
Other Name: ready-to-use therapeutic food
Experimental: Nutritional supplementation
Children included in the study with moderate acute malnutrition receive Plumpy Sup: 60kcal/kg/day, limited to 4 doses/day.
Dietary Supplement: Plumpy Sup
Other Name: ready-to-use supplementary food
- Successful nutritional rehabilitation [ Time Frame: up to 12 months ]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
- long-term effectiveness [ Time Frame: 3 months ]the child maintains stable weight (or gains weight) 3 months after reaching target weight.
- long-term effectiveness [ Time Frame: 6 months ]the child maintains stable weight (or gains weight) 6 months after reaching target weight.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101852
|Principal Investigator:||Karim Diop, MD||Division de Lutte contre le Sida et les IST, Dakar, Senegal|
|Principal Investigator:||Fatou Niasse-Traore, MD||Comité National de Lutte contre le Sida, Dakar, Senegal|