Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR202001816232398 Date of Approval: 06/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessment of dietary diversity and nutritional support for HIV-infected children in West Africa, the WADANUT study
Official scientific title The WADANUT study
Brief summary describing the background and objectives of the trial In 2014-2016, a nutritional intervention was proposed to HIV-infected children, receiving antiretroviral therapy (ART) or not, in care <10 years of age, with caregivers’ consent, in 5 HIV pediatric clinics, in Benin, Togo and Côte d’Ivoire. Weight deficiency was assessed using two definitions: wasting (Weight for Height Z-score [WHZ] for children<5 years old or Body-Mass-Index for Age [BAZ] for ≥5 years) and underweight (Weight for Age Z-score [WAZ]) according to the WHO child growth standards. Combining these indicators, we defined 3 categories of nutritional support: 1/ children with severe malnutrition (WAZ and/or WHZ/BAZ <-3 Standard Deviations [SD]) were supported with Ready-To-Use Therapeutic Food (RUTF), 2/ those with moderate malnutrition (WAZ and/or WHZ/BAZ = [-3;-2[ SD) were supported with fortified blended flours produced locally in each country, 3/ those non malnourished (WAZ and WHZ/BAZ ≥-2 SD) received nutritional counselling only. Children were followed monthly over 6 months. Dietary Diversity Score (DDS) using a 24h recall was measured at the first and last visit of the intervention.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/01/2016
Actual trial start date 01/01/2016
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 31/12/2016
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 326
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutritional support 6 months Two malnutrition indicators, wasting and underweight, were combined to define three degrees of weight deficiency: severe, moderate or non-deficient. Wasting (also named acute malnutrition) was defined by Weight-for-Height Z-score (WHZ) for children aged less than five years of age and by Body-Mass-Index-for-age Z-score (BAZ) for children aged five years or older. Underweight was defined by Weight-for-age Z-score (WAZ). Severe weight deficiency was then defined by at least one Z-score (WHZ/BAZ or WAZ) lower than -3 Standard Deviations (SD); moderate weight deficiency by at least one Z-score between -3 and -2 SD, both Z-scores being equal or higher than -3SD; and no weight deficiency by both Z-scores equal or higher than -2 SD. Children were given a specific nutritional support according to these three malnutrition categories, following WHO nutritional guidelines for HIV-infected children (15). First, those who don’t have any weight deficiency were offered with nutritional counseling messages for them and their caregivers by the pediatricians. Each participant center adopted their own counseling strategy, using UNICEF pictures and brochures for example. Second, those with moderate weight deficiency were given fortified blended flours (FBF) locally produced: Cereso in Benin, Nutrisoy in Togo and CSB+ in Côte d’Ivoire. Children were supplemented with a specific amount of product according to their age: 85, 75 and 55 Kcal/kg/day for children aged 0-2 years, 2-5 years and 5-10 years respectively. Third, those with severe weight deficiency were all supplemented with Ready-To-Use Therapeutic Food (RUTF), using Plumpy Nut. The supplemental energy requirements were 220 and 100 Kcal/kg/day for children aged 0-5 years and 5-10 years respectively. Children with severe acute malnutrition requiring hospitalization or oedemous symptoms were not included and referred to nutritional rehabilitation units. 100
Control Group Nutritional counseling 6 months Those who don’t have any weight deficiency were offered with nutritional counseling messages for them and their caregivers by the pediatricians. Each participant center adopted their own counseling strategy, using UNICEF pictures and brochures for example. 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- children living with HIV infectino (confirmed diagnosis) - aged less than 10 years of age at inclusion - followed in the participant clinics Children with severe acute malnutrition requiring hospitalization or oedemous symptoms were not included and referred to nutritional rehabilitation units. Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 0 Year(s) 10 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/11/2013 Comite National d Ethique des Sciences de la Vie et de la Sante
Ethics Committee Address
Street address City Postal code Country
Avenue Lamblin Abidjan 00225 Cote Divoire
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recovery of malnutrition defined as having WAZ and WHZ/BAZ Z-scores higher or equal to -2 SD 6 months, or last visit if happening before 6 months
Secondary Outcome Dietary diversity score evolution 6 months, or last visit if happening before 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre Hospitalier Universitaire Yopougon Service Pediatrie S 804 Abidjan Cote Divoire
CePReF Centre de Prise en charge et de Formation enfant Yopougon Abidjan Cote Divoire
Centre Hospitalier Universitaire Cocody Service Pediatrie Boulevard de l Universite Abidjan Cote Divoire
Centre Hospitalier Universitaire Tokoin Rue Kolina Lome Togo
Centre National Hospitalier Universitaire Ave Jean-Paul II Cotonou Benin
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health 6710 Rockledge Dr Bethesda United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institutes of Health 6710 Rockledge Dr Bethesda United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Ayoko Ephoeviga CHU Sylvanus Olympio Lome Togo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Valeriane Leroy valeriane.leroy@inserm.fr +33561145957 37 Allees Jules Guesde
City Postal code Country Position/Affiliation
Toulouse 31073 France Inserm U1027 Universite Toulouse III Paul Sabatier
Role Name Email Phone Street address
Scientific Enquiries Julie Jesson julie.jesson@univ-tlse3.fr +33683619227 37 Allees Jules Guesde
City Postal code Country Position/Affiliation
Toulouse France Inserm U1027 Universite Toulouse III Paul Sabatier
Role Name Email Phone Street address
Public Enquiries Elodie Rabourding elodie.rabourdin@u-bordeaux.fr +33687230753 146 Rue Leo Saignat
City Postal code Country Position/Affiliation
Bordeaux France Inserm U1219
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets generated and/or analysed during the current study are not publicly available, as data ownership remains with the participating sites. Each site has approval from its own local Institutional Review Board to collect routine data on patients and to transfer those data anonymously to the IeDEA West Africa collaboration. Reasonable request for access to data can be addressed to the corresponding author. Study Protocol Once the article will be published (for now, planned to be submit after completing the trial registration retrospectively) Controlled access, data access upon reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Overall, 326 children were included, 48% were girls. At the start of the intervention, 66% were aged 5-10 years of age, 91% were on ART, and 17% were severely immunodeficient (CD4 <250 cells/mL or CD4%<15). Twenty-nine (9%) were severely malnourished, 63 (19%) moderately malnourished and 234 (72%) non-malnourished. After 6 months, 9/29 (31%) and 31/63 (48%) recovered from severe and moderate malnutrition respectively. The median DDS was 8 (IQR 7-9) in Côte d’Ivoire and Togo, 6 (IQR 6-7) in Benin. Mean DDS was 4.3/9 (sd 1.2) at first visit, with a lower score in Benin, but with no difference between first and last visit (p=0.907), either by intervention groups (p-value=0.767). 13/12/2019 29/10/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://drive.google.com/open?id=1sV-21ZvC1NyTPfuBuDN6X5Qs1W8M2Yny
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 13/12/2019 Letter was missing TRUE, Comite National d Ethique des Sciences de la Vie et de la Sante , Avenue Lamblin, Abidjan, 00225, Cote Divoire, , 01 Nov 2013, 0022520321375, julie.jesson@univ-tlse3.fr, TRUE, Comite National d Ethique des Sciences de la Vie et de la Sante , Avenue Lamblin, Abidjan, 00225, Cote Divoire, , 01 Nov 2013, 0022520321375, julie.jesson@univ-tlse3.fr, 9588_8846_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 13/12/2019 Letter added and e-mail adress updated TRUE, Comite National d Ethique des Sciences de la Vie et de la Sante , Avenue Lamblin, Abidjan, 00225, Cote Divoire, , 01 Nov 2013, 0022520321375, julie.jesson@univ-tlse3.fr, 9588_8846_4737.pdf TRUE, Comite National d Ethique des Sciences de la Vie et de la Sante , Avenue Lamblin, Abidjan, 00225, Cote Divoire, , 01 Nov 2013, 0022520321375, lou.penali@gmail.com, 9588_8846_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/12/2019 Accronym spelled CHU Yopougon Service Pediatrie, S 804 , Abidjan, , Cote Divoire Centre Hospitalier Universitaire Yopougon Service Pediatrie, S 804 , Abidjan, , Cote Divoire
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/12/2019 Accronym spelled CHU Cocody Service Pediatrie, Boulevard de l Universite, Abidjan, , Cote Divoire Centre Hospitalier Universitaire Cocody Service Pediatrie, Boulevard de l Universite, Abidjan, , Cote Divoire
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/12/2019 Accronym spelled CHU Tokoin, Rue Kolina, Lome, , Togo Centre Hospitalier Universitaire Tokoin, Rue Kolina, Lome, , Togo
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/12/2019 Accronym spelled CNHU, Ave Jean-Paul II, Cotonou, , Benin Centre National Hospitalier Universitaire, Ave Jean-Paul II, Cotonou, , Benin
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/12/2019 Accronym spelled CePReF enfant, Yopougon, Abidjan, , Cote Divoire CePReF Centre de Prise en charge et de Formation enfant, Yopougon, Abidjan, , Cote Divoire
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 13/12/2019 IPD Statement completed No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 13/12/2019 IPD Statement completed The datasets generated and/or analysed during the current study are not publicly available, as data ownership remains with the participating sites. Each site has approval from its own local Institutional Review Board to collect routine data on patients and to transfer those data anonymously to the IeDEA West Africa collaboration. Reasonable request for access to data can be addressed to the corresponding author.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 13/12/2019 IPD Statement completed Once the article will be published (for now, planned to be submit after completing the trial registration retrospectively)
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 13/12/2019 IPD Statement completed Controlled access, data access upon reasonable request
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results summary 13/12/2019 Results updated Overall, 326 children were included, 48% were girls. At the start of the intervention, 66% were aged 5-10 years of age, 91% were on ART, and 17% were severely immunodeficient (CD4 <250 cells/mL or CD4%<15). Twenty-nine (9%) were severely malnourished, 63 (19%) moderately malnourished and 234 (72%) non-malnourished. After 6 months, 9/29 (31%) and 31/63 (48%) recovered from severe and moderate malnutrition respectively. The median DDS was 8 (IQR 7-9) in Côte d’Ivoire and Togo, 6 (IQR 6-7) in Benin. Mean DDS was 4.3/9 (sd 1.2) at first visit, with a lower score in Benin, but with no difference between first and last visit (p=0.907), either by intervention groups (p-value=0.767).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of results summaries 13/12/2019 Results updated 13 Dec 2019
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 13/12/2019 Results updated 29 Oct 2019
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 13/12/2019 Results updated https://drive.google.com/open?id=1aUFyciiVbYZVZ-XDDsLr_x3E6PZKzE_w
Section Name Field Name Date Reason Old Value Updated Value
Reporting Baseline characteristics 13/12/2019 Results updated The baseline characteristics of the 326 children included were the following: 48% were from Côte d’Ivoire, 28% from Benin and 24% from Togo; their median age was 6.5 years (interquartile range [IQR] 3.8-8.2), 48% were females, and 28% were orphans of at least one parent. There were no differences by countries on these socio-demographic characteristics, except for the main caregiver who were one of the parents in 93% of the cases in Togo versus 86% in Benin and 75% in Côte d’Ivoire (p=0.001). ART coverage at inclusion ranged from 87% in Benin to 100% in Togo (p=0.006), with globally 77% of ART-treated children with a regimen based on NRTIs (Nucleoside Reverse Transcriptase Inhibitors). The median duration on ART was 2.6 years on ART (IQR 1.0-4.9). Immunological and clinical status at inclusion differed by countries, with the lowest rates of severe immunodeficiency (8%) and advanced WHO stage (3% for stage 3 or 4) in Togo and the highest rates in Côte d’Ivoire (21% and 46% respectively, p<0.001). Viral load was not collected routinely in Benin and Togo resulting in high rates of missing data (60%). In the previous six months, respectively 2%, 7% and 5% of tuberculosis, pneumonia and diarrhea cases were reported. Malaria was reported in 14% overall, with the highest rate observed in Togo (42%) (Table 1). The prevalence of malnutrition at inclusion was similar between countries, with 25% underweight, 10% wasting and 29% stunted overall.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Participant flow 13/12/2019 Results updated During the inclusion period, 870 eligible children attended the participating centers. Of them, 409 (47%) children were included, 83 (20%) were thereafter excluded of the analysis because of missing information at inclusion (28) and during follow-up (45). Children attending the study sites during the inclusion period but who were not enrolled in the study were younger compared to those enrolled (% age 0-2 years: 19% vs 8%, p<0.001), more frequently followed in Côte d’Ivoire sites (68% vs 48%), and more often severely immunodeficient (23% vs 17%). In addition, these children were not systematically screened for weight and height, resulting in a high rate of missing data (from 24% for underweight to 36% for stunting).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Adverse events 13/12/2019 Results updated No adverse events were recorded
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measures description 13/12/2019 Results updated After 6 months (or at last visit if happened sooner), 31/63 (49%) of children in the FBF group have recovered from moderate malnutrition. The rate of malnutrition recovery for the FBF group did not differ by age, sex, immunodeficiency by age and ART duration, but was higher in Côte d’Ivoire where 74% of the recoveries occurred (p-value=0.013). Also, 75% of children who did not recover were stunted, compared to 48% of children who recovered (p-value=0.030). In the RUTF group, 9/29 (31%) recovered completely from their severe malnutrition, and 7/29 (24%) recovered partially, remaining moderately malnourished at the end of the study. The rate of complete malnutrition recovery did not differ by age, country, immunodeficiency by age and ART duration. Trends for a higher recovery in boys compared to girls was seen (7/15 vs 2/14) but the sample was too small to conclude for a significant difference (p-value=0.109). Similarly, stunting seemed to alter the rate of recovery. Also, 11/234 (5%) of children initially non-malnourished have developed a moderate malnutrition during follow-up but no differences were seen according to characteristics at inclusion.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 13/12/2019 Results updated https://drive.google.com/open?id=1sV-21ZvC1NyTPfuBuDN6X5Qs1W8M2Yny
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 13/12/2019 IPD Statement completed Study Protocol
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measure document 13/12/2019 Results updated 9588_6936_4738.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 13/12/2019 Results updated No Yes
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 13/12/2019 Collaborator added Ayoko Ephoeviga, CHU Sylvanus Olympio, Lome, , Togo