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AzTrials

MalnutritionSNAC'SNCT03101852

Nutritional Rehabilitation in Senegalese HIV-infected Children and Adolescents

A study testing Plumpy Nut and Plumpy Sup in people with Malnutrition and HIV/AIDS, run by Institut de Recherche pour le Developpement.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 18 years
Conditions the study is for
Malnutrition, HIV/AIDS
What is being tested?
Plumpy Nut and Plumpy Sup
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
No sites listed yet
Study dates
Apr 2015to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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

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.

Read the detailed description

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 outcomes). Long-term (3 months and 6 months after discharge) weight growth and relapse will be assessed Acceptability of the intervention will be assessed using quantitative methods (observance to RUF prescription, feeding modalities, organoleptic appreciation, etc.) and qualitative methods (focus group and interviews about perceptions among children > 7 years and health workers).

The SNACS study was carried out in Senegal from April 2015 to January 2017 in 12 public paediatric clinics: two in the Dakar district, the capital city, (Albert Royer National Paediatric Hospital and Roi Baudouin Hospital) and 10 in decentralized settings (Regional Hospitals of Saint Louis, Louga, Mbour, Kaoloack, Ziguinchor and Kolda; Health centres of Thiès, Nioro du Rip, Bignona and Kolda). Study implementation was gradual, starting with the central sites in April 2015 and ending with the Kolda sites in March 2016.

Methods:

This is an open cohort study (intervention/evaluation) conducted over 2 years. Children with SAM will be enrolled in a rehabilitation protocol, using Plumpy Nut until the target weight is reached, BMI-z > -2. Children with MAM will be enrolled in a rehabilitation protocol, using Plumpy Sup. At enrollment and at discharge from the rehabilitation protocols, a blood sample will be collected for an immunovirological, biological and selected proteins and micronutrients assessment. At each visit, a clinical examination and anthropometric measurements will be performed.

At enrollment and after discharge, focus groups will be conducted with children > 7 years about their understanding and perception of the study protocol and of the nutritional care. Before enrollments start and at the end of the study, interviews will be conducted with the health workers involved in the study to explore their understanding of the study and their perceptions about the acceptability, effectiveness and feasibility of the nutritional rehabilitation of HIV children. Overall acceptability of RUF will be assessed in children by questionnaires at 3 time points during the study follow-up.

Expected outcomes:

Implementation of the recent recommendations on early ART initiation in children should allow the integration of targeted and appropriate nutritional interventions. The SNAC's Study will disseminate the first scientific data on modalities, acceptability and efficacy of nutritional rehabilitation in HIV-infected older children and adolescents in Africa. As it complies with international and national recommendations, it will also provide programmatic data, with regards to feasibility of outpatient nutritional rehabilitation using RUTF in HIV-infected adolescents, to national stakeholders and decision makers. It is ultimately expected to facilitate effective integration of these vulnerable patients both in nutritional care guidelines and follow-up health structures.

Being tested
Plumpy Nut, Plumpy Sup
Keywords
severe acute malnutrition, moderate acute malnutrition, HIV-infection, adolescents, antiretroviral, Africa, ready-to-use food, outpatient care
Medical subject headings
Malnutrition, Acquired Immunodeficiency Syndrome, Severe Acute Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plumpy NutDietary supplement

    Also called ready-to-use therapeutic food

  • Plumpy SupDietary supplement

    Also called ready-to-use supplementary food

Study groups in NCT03101852
Study groupRoleWhat they receive
Nutritional therapyExperimentalChildren 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
Receives: Dietary Supplement: Plumpy Nut
Nutritional supplementationExperimentalChildren included in the study with moderate acute malnutrition receive Plumpy Sup: 60kcal/kg/day, limited to 4 doses/day.
Receives: Dietary Supplement: Plumpy Sup

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 12 months

Secondary outcomes (2)
  1. long-term effectiveness

    the child maintains stable weight (or gains weight) 3 months after reaching target weight.

    Measured: 3 months

  2. long-term effectiveness

    the child maintains stable weight (or gains weight) 6 months after reaching target weight.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2017
  2. Study startApr 2015
  3. Primary completionMar 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03101852
Sponsor's protocol ID
14SANIN203
Acronym
SNAC'S
Status last verified
Mar 2020
First submitted
22 Mar 2017
Last updated
4 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32414346
  • 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.

    PubMed 30624827

Questions about this trial

What is this clinical trial studying?

A study testing Plumpy Nut and Plumpy Sup in people with Malnutrition and HIV/AIDS, run by Institut de Recherche pour le Developpement.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful nutritional rehabilitation (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03101852, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.

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