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Trial record 1 of 1 for:    NCT03101852
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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
Sponsor:
Collaborators:
Global Fund
Sidaction
UNICEF
United Nations World Food Programme (WFP)
Information provided by (Responsible Party):
Cecile Cames, Institut de Recherche pour le Developpement

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.

Condition or disease Intervention/treatment Phase
Malnutrition HIV/AIDS Dietary Supplement: Plumpy Nut Dietary Supplement: Plumpy Sup Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. long-term effectiveness [ Time Frame: 3 months ]
    the child maintains stable weight (or gains weight) 3 months after reaching target weight.

  2. long-term effectiveness [ Time Frame: 6 months ]
    the child maintains stable weight (or gains weight) 6 months after reaching target weight.



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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Sponsors and Collaborators
Institut de Recherche pour le Developpement
Global Fund
Sidaction
UNICEF
United Nations World Food Programme (WFP)
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cecile Cames, Principal investigator, Researcher, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT03101852    
Other Study ID Numbers: 14SANIN203
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cecile Cames, Institut de Recherche pour le Developpement:
severe acute malnutrition
moderate acute malnutrition
HIV-infection
adolescents
antiretroviral
Africa
ready-to-use food
outpatient care
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders