NCT03101852

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

March 22, 2017

Last Update Submit

March 2, 2020

Conditions

MalnutritionHIV/AIDS

Keywords

severe acute malnutritionmoderate acute malnutritionHIV-infectionadolescentsantiretroviralAfricaready-to-use foodoutpatient care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • long-term effectiveness

    3 months

  • long-term effectiveness

    6 months

Study Arms (2)

Nutritional therapy

EXPERIMENTAL

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

Nutritional supplementation

EXPERIMENTAL

Children included in the study with moderate acute malnutrition receive Plumpy Sup: 60kcal/kg/day, limited to 4 doses/day.

Dietary Supplement: Plumpy Sup

Interventions

Plumpy NutDIETARY_SUPPLEMENT
Also known as: ready-to-use therapeutic food
Nutritional therapy
Plumpy SupDIETARY_SUPPLEMENT
Also known as: ready-to-use supplementary food
Nutritional supplementation

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • physical and/or mental disability incompatible with the study follow-up
  • living far from the study site (about more than 50km)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Niasse F, Varloteaux M, Diop K, Ndiaye SM, Diouf FN, Mbodj PB, Niang B, Diack A, Cames C. Adherence to ready-to-use food and acceptability of outpatient nutritional therapy in HIV-infected undernourished Senegalese adolescents: research-based recommendations for routine care. BMC Public Health. 2020 May 15;20(1):695. doi: 10.1186/s12889-020-08798-z.

    PMID: 32414346DERIVED

  • Hejoaka F, Varloteaux M, Desclaux-Sall C, Ndiaye SM, Diop K, Diack A, Niasse F, Cames C. Improving the informed consent process among HIV-infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal. Trop Med Int Health. 2019 Mar;24(3):294-303. doi: 10.1111/tmi.13202. Epub 2019 Jan 24.

    PMID: 30624827DERIVED

MeSH Terms

Conditions

MalnutritionAcquired Immunodeficiency SyndromeSevere Acute Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Researcher

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 5, 2017

Study Start

April 1, 2015

Primary Completion

March 1, 2017

Study Completion

September 1, 2017

Last Updated

March 4, 2020

Record last verified: 2020-03