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.
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.
- Conditions
- Malnutrition, HIV/AIDS
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Dietary Supplement: Plumpy Sup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
long-term effectiveness
the child maintains stable weight (or gains weight) 3 months after reaching target weight.
Measured: 3 months
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.
- First posted5 Apr 2017
- Study startApr 2015
- Primary completionMar 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Global Fund, Sidaction, UNICEF, United Nations World Food Programme (WFP)
- Responsible party
- Principal investigator, Cecile Cames, Institut de Recherche pour le Developpement
- Investigators
- Karim Diop, MD, Principal investigator, Division de Lutte contre le Sida et les IST, Dakar, SenegalFatou Niasse-Traore, MD, Principal investigator, Comité National de Lutte contre le Sida, Dakar, Senegal
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 32414346Hejoaka 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03101852
- Acronym / sponsor ID
- SNAC'S / 14SANIN203
- Conditions
- Malnutrition, HIV/AIDS
- Keywords
- severe acute malnutrition, moderate acute malnutrition, HIV-infection, adolescents, antiretroviral, Africa, ready-to-use food, outpatient care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Global Fund, Sidaction, UNICEF, United Nations World Food Programme (WFP)
- Study start
- Apr 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional therapy | Experimental | Dietary Supplement: Plumpy NutChildren 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 |
| Nutritional supplementation | Experimental | Dietary Supplement: Plumpy SupChildren included in the study with moderate acute malnutrition receive Plumpy Sup: 60kcal/kg/day, limited to 4 doses/day. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy
- physical and/or mental disability incompatible with the study follow-up
- living far from the study site (about more than 50km)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plumpy NutAlso: ready-to-use therapeutic food | Dietary supplement | Nutritional therapy |
| Plumpy SupAlso: ready-to-use supplementary food | Dietary supplement | Nutritional supplementation |
Primary outcome
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
2 secondary outcomes
long-term effectiveness
Time frame: 3 months
long-term effectiveness
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 32414346Niasse 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.
- Derived from this study: PubMed 30624827Hejoaka 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.
- Individual participant dataSharing planned: Undecided
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Diop, MD principal investigator
Division de Lutte contre le Sida et les IST, Dakar, Senegal
Fatou Niasse-Traore, MD principal investigator
Comité National de Lutte contre le Sida, Dakar, Senegal
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.