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: pactr.samrc.ac.za
Trial no.: PACTR202201828512110 Date of Approval: 24/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title School-aged follow-up of the Sanitation, Hygiene, Infant Nutrition Efficacy (SHINE) Cluster Randomised Trial
Official scientific title School-aged follow-up of the Sanitation, Hygiene, Infant Nutrition Efficacy (SHINE) Cluster Randomised Trial
Brief summary describing the background and objectives of the trial Stunting affects 22% (149 million) children under 5 years. Stunting is associated with increased child mortality, long-term cognitive and health deficits, poorer school performance and lower adult earnings. Improved infant and young child feeding (IYCF) targets the most vulnerable window between 6-18 months of age but only increases linear growth modestly (+0.11 HAZ). Water, sanitation and hygiene (WASH) has shown a minimal impact on growth, but may have later impacts on neurodevelopment. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial (clinicaltrials.gov NCT01824940) was a 2x2 factorial, cluster-randomized trial in rural Zimbabwe conducted between 2012-2017. Women were enrolled in early pregnancy, with detailed data collection on home, maternal, birth and early-life factors. Clusters were randomised to standard of care, IYCF, WASH or IYCF plus WASH. All available children born during the trial were previously followed up to 18 months of age, with primary outcomes of height-for-age Z-score and haemoglobin. This follow-up study will further evaluate a subgroup of 1300 of these children born into the SHINE trial, who are now aged 7 years. It will measure their growth, physical and cognitive function: Following written informed consent, we will re-enrol 1000 HIV-unexposed children (approximately 250 per arm), and 300 children who were HIV-exposed uninfected (HIV-negative children born to HIV-positive mothers). Outcomes will be measured using the School-aged Health, Activity, Resilience, Anthropometry and Neurocognitive (SAHARAN) toolbox at a single home visit. Children will then be followed monthly by village health workers to evaluate illness episodes from 7-12 years of age, and undergo an annual assessment using an abbreviated version of the SAHARAN toolbox.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SHINE follow up
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Nutrition and Water, Sanitation and Hygiene
Anticipated trial start date 30/03/2021
Actual trial start date
Anticipated date of last follow up 16/07/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1300
Actual target sample size (number of participants) 1275
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program 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 IYCF Daily supplement for ages 6 to18 months 1 year In the IYCF arms, households received a 20 g small-quantity lipid-based nutrient supplement (LNS) to be fed daily to the infant from 6 to 18 months of age, and messages promoting nutrient-dense, diverse infant diets processed to facilitate mastication and swallowing, with frequent responsive feeding during illness. 325
Experimental Group WASH Latrine built and monthly visits enrolment to 18 months age In the WASH arms, builders installed a ventilated improved pit latrine and two handwashing stations; a mat and play space were provided to reduce geophagia and contact with animals; and VHW provided regular deliveries of soap and chlorine solution and messages promoting their use. 325
Control Group Standard of care Monthly mesuring visits 18 months In the SOC arm, VHW promoted early and exclusive breastfeeding, antenatal care including PMTCT and immunizations 325 Uncontrolled
Experimental Group IYCF WASH Latrine built and monthly visits, daily lipid-based supplement from 6 to 18 months. IYCF for 6 to 18 months, WASH from enrolment to 18 months 1 intervention arm had both IYCF (providing both nutrition supplements (6-18 months)) as well as WASH (latrine from enrolment, monthly visits to 18 months). 325
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Enrolled in SHINE and had primary outcome measurement at 18 months of age - Mother tested and HIV status known in pregnancy - Written informed consent of parent / guardian - Age 7 years (defined as between 7 years and 7 years + 364 days of age) - Resident in Shurugwi district - <7 years or >8 years of age - Not resident in Shurugwi district Child: 6 Year-12 Year 7 Year(s) 8 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 08/02/2021 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Mazowe Street Harare PO CY573 Zimbabwe
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 04/11/2021 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Mazowe Street Harare PO CY573 Zimbabwe
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 06/04/2021 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Mazowe Street Harare PO CY573 Zimbabwe
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 25/06/2021 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Mazowe Street Harare PO CY573 Zimbabwe
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 17/04/2023 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
20 Cambridge Rd Harare H20 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mental processing index MPI from Kaufmann Assessment Battery for Children KABC-2 7 years
Secondary Outcome Total of Writing Reading and Arithmetic Test score 7 years
Secondary Outcome Fine motor from Total time to complete finger tapping task 7 years
Secondary Outcome Plus EF executive function score 7 years
Secondary Outcome Height, weight, head circumference, MUAC 7 years
Secondary Outcome Kaufmann subtest scores, SAT subtest scores, individual fine motor scores, Plus-EF subtest scores and reaction times 7 years
Secondary Outcome Bioimpedance-based lean mass index, phase angle 7 years
Secondary Outcome Sum of skinfold thickness 7 years
Secondary Outcome Knee- heel length 7 years
Secondary Outcome Waist circumference, calf circumference, 7 years
Secondary Outcome Subscapular, triceps, suprailiac and calf skinfold thicknesses 7 years
Secondary Outcome Average grip strength for both hands 7 years
Secondary Outcome Grip strength in dominant and non-dominant hand 7 years
Secondary Outcome Broad jump distance 7 years
Secondary Outcome Shuttle run test level 7 years
Secondary Outcome Composite outcome of combined standardised scores of grip strength, broad jump and shuttle run test 7 years
Secondary Outcome Resting blood pressure and blood pressure 1 minute after exercise 7 years
Secondary Outcome Haemoglobin level 7 years
Secondary Outcome Acute illnesses in school age health and visits to traditional healer, clinic and hospital 7 to 12 years
Secondary Outcome Annual monitoring visits that measure child growth, body composition, handgrip strength, literacy, numeracy and executive function. 8-12 years
Secondary Outcome Child Socioemotional scale 7 - 12 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shurugwi District Shurugwi Hub Shurugwi Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
National Institutes of Health 10 Center Drive Bethesda 200892 United States of America
Thrasher Research Fund 68 S. Main Street Salt Lake City UT 84101 United States of America
Innovative Methods and Metrics for Agriculture and Nutrition Actions Keppel Street London WC1E 7HT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zvitambo Institute for Maternal and Child Health Research 16 Lauchlan Avenue - Meyrick Park Harare Zimbabwe Non-profit Research Organisation
COLLABORATORS
Name Street address City Postal code Country
Professor Melissa Gladstone Institute of Translational Medicine-Crown Street Liverpool L69 3BX United Kingdom
Professor Jonathan Wells Institute of Child Health-30 Guilford Street London WC1N1EH United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Andrew Prendergast a.prendergast@qmul.ac.uk +442078822269 Blizard Institute, Queen Mary University of London, 4 Newark Street
City Postal code Country Position/Affiliation
London E12AT United Kingdom Professor of paediatric infection and immunology
Role Name Email Phone Street address
Public Enquiries Virginia Sauramba v.sauramba@zvitambo.com +263242306028 Zvitambo Institute for Maternal and Child Health Research, 16 Lauchlan Avenue, Meyrick Park
City Postal code Country Position/Affiliation
Harare Zimbabwe Research Administration and Compliance Manager
Role Name Email Phone Street address
Scientific Enquiries Lisa Langhaug l.langhaug@zvitambo.com +263242306028 Zvitambo Institute for Maternal and Child Health Research, 16 Lauchlan Avenue, Meyrick Park
City Postal code Country Position/Affiliation
Harare Zimbabwe Associate Director for Research Administration
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data included in the primary analysis will be made available as de-identified data together with a data dictionary. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months after publication of the primary analysis Researchers should provide a methodologically sound plan to access data for the aims outlined in the plan. Proposals should be directed to Virginia Sauramba at v.sauramba@zvitambo.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://osf.io/w93hy/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information