Clinical Trial: Nutritional Rehabilitation in Senegalese HIV-infected Children and Adolescents

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

Background:

Severe (SAM, BMI-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. Scaling-up of ART decreased morbimortality in children in low-income settings and thus allowed HIV-infection to become, to some extent, a chronic disease. However, appropriate and targeted nutritional interventions take a long time to be assessed with the aim of their integration in the "global care" of HIV infection, thus jeopardizing in these patients who go through adolescence the successes achieved so far. Many clinical trials reported a greater efficacy of the ready-to-use therapeutic foods (RUTF) in the nutritional rehabilitation compared with standard interventions, among up to five children, with or without HIV-infection. Since 2007, the United Nations recommend their use for the outpatient nutritional rehabilitation of severely malnourished children and since 2009, also in HIV-infected adolescents.

Objectives :

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.

Will be specifically assessed:

Effectiveness of nutritional rehabilitation in terms of catch-up weight growth, of immunologic status improvements, of muscular mass gain and of micronutrients status (including the correlation within these outco
Sponsor: Institut de Recherche pour le Developpement

Current Primary Outcome: Successful nutritional rehabilitation [ Time Frame: up to 12 months ]

the child reach his/her target weight defined as weight-for-height > 1.5 z-score in children < 5years; body mass index for age > 1.5 z-score in children >= 5 years


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Institut de Recherche pour le Developpement

Dates:
Date Received: March 22, 2017
Date Started: April 2015
Date Completion: September 2017
Last Updated: March 29, 2017
Last Verified: March 2017