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.: PACTR202009897660297 Date of Approval: 03/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title VITALITY Trial
Official scientific title VITamin D for AdoLescents with HIV to reduce musculoskeletal morbidity and ImmunopaThologY
Brief summary describing the background and objectives of the trial Of the 2 million children with HIV (CWH) globally, 90% live in sub-Saharan Africa (SSA). The scale-up of antiretroviral therapy (ART) has improved survival so that CWH are now increasingly reaching adolescence. However, childhood HIV infection is associated with a heavy burden of comorbidities, which have received little focus. Growth failure is one of the most common manifestations of HIV infection and is associated with impaired skeletal development. The purpose of this trial is to establish whether supplementation with vitamin D and calcium improves musculoskeletal health among peri-pubertal adolescents living with HIV. If effective, it is anticipated that intervention during this critical period of growth will optimise bone accrual, conferring a reduction in future adult fracture risk. We will conduct an individually randomised, double-blind, placebo-controlled trial to investigate the efficacy of weekly high-dose (20,000IU) vitamin D3 (cholecalciferol) plus 500mg calcium carbonate daily supplementation for 48 weeks on musculoskeletal health and immune-regulation in peripubertal CWH aged 11-19 years in Zambia and Zimbabwe
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VITALITY
Disease(s) or condition(s) being studied Infections and Infestations,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/11/2020
Actual trial start date 04/02/2021
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date 03/10/2023
Anticipated target sample size (number of participants) 840
Actual target sample size (number of participants) 842
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 Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo One placebo tablet once weekly One placebo tablet once daily 48 weeks Participants will be randomised to either receiving Vitamin D3 20,000iu/placebo once weekly with calcium carbonate 500mg/placebo once a day for 48 weeks 420 Placebo
Experimental Group Vitamin D3 Calcium carbonate Vitamin D3 20,000iu Calcium Carbonate 500mg once daily 48 weeks Participants randomised to the intervention arm will receive one tablet of vitamin D3 weekly and one tablet of calcium carbonate 500mg once daily 420
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 11-19 years 2. Perinatally-acquired HIV infection 3. Taking ART for at least 6 months 4. A firm home address accessible for visiting and intending to remain there for 96 weeks 5. Willing to agree to participate in the study and to give samples of blood and rectal swabs 6. Defined care-giver able to provide informed consent for child to participate in trial (for those aged below 18 years, unless emancipated minor) 7. HIV status disclosed to participant for those aged older than 12 years (13-19 years) 1. Any condition (except HIV) that may prove fatal during the study period (e.g. malignancy, end-stage HIV disease or other conditions deemed likely fatal by the trial physician) 2. Taking TB treatment 3. Pregnant or breast-feeding 4. Condition likely to lead to lack of understanding of study procedures or to uncooperative behaviour e.g. neurocognitive disease, developmental delay or psychiatric illness 5. History of thyrotoxicosis, kidney stones, lymphoma 6. History of chronic renal disease 7. History of hypercalcemia 8. History of a disorder of phosphate metabolism 9. Physical or radiological (if available) signs of rickets 10. History of osteomalacia 11. Living in the same household as a trial participant (to avoid inadvertent mix-up of trial drugs) Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 11 Year(s) 19 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 17/08/2020 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel St, Bloomsbury, London WC1E 7HT United Kingdom
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 17/08/2020 UNIVERSITY OF ZAMBIA BIOMEDICAL RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Ridgeway Campus Lusaka 0000 Zambia
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 17/12/2020 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
20 Cambridge Road, Avondale Harare 0000 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome DXA measured total body less-head bone mineral density Z-score (TBLH-BMD) 48 weeks
Secondary Outcome Lumbar spine bone mineral apparent density Z-score 48 and 96 weeks
Secondary Outcome Lean muscle mass (kg) 48 and 96 weeks
Secondary Outcome Grip strength (kg) 48 and 96 weeks
Secondary Outcome No. of respiratory tract infections 48 and 96 weeks
Secondary Outcome TBLH-BMD Z-score adjusted for height 48 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sally Mugabe Central Hospital Southerton Harare Zimbabwe
University Teaching Hospitals Nationalist Road Lusaka Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP PO Box 93015 The Hague 2509 AA Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health and Child Care Kaguvi Building, 4th Floor Central Avenue Harare 0000 Zimbabwe
University of Bristol Tyndall Ave Bristol United Kingdom
University of Oxford Old Road Campus Oxford United Kingdom
Research Center Borstel Parkallee 1 - 40 Borstel Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rashida Ferrand rashida.ferrand@lshtm.ac.uk 00442079272577 10 Seagrave Rd
City Postal code Country Position/Affiliation
Harare Zimbabwe Professor of International Health LSHTM
Role Name Email Phone Street address
Public Enquiries Anna Shepherd anna.shepherd@lshtm.ac.uk 00442076368636 Keppel Street
City Postal code Country Position/Affiliation
London United Kingdom Communications Officer
Role Name Email Phone Street address
Scientific Enquiries Rashida Ferrand rashida.ferrand@lshtm.ac.uk 00442079272577 Keppel Street
City Postal code Country Position/Affiliation
London United Kingdom Professor of International Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Cleaned and locked datasets will have additional anonymization (e.g. removal of exact birthdate), and be archived with a codebook in a curated repository accessible via catalogue search. This protocol, CRFs, the analytical plan and metadata will also be deposited. Data will be primarily shared with scientific collaborators, but we will as far as possible facilitate data sharing with any group requesting access to individual patient records, using anonymised data. Where appropriate, and with the proper safeguards, data will be made freely available through LSHTM repository. Beside the original data, anonymised databases will be created and stored with all relevant data to facilitate any data transfer requests that are made subsequently. Priority will be given to local investigators and publicly funded international investigators with data management and sharing policies in line with those of the regulations of the ethical agencies in Zambia and Zimbabwe as well as LSHTM. The governance of data and materials generated by the programme, and the monitoring of their use either locally or abroad, is an area that is currently under detailed review by ourselves. Ethical clearance will be sought before data are transferred to other groups for secondary analysis. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Protocol and informed consent forms will be available for sharing once recruitment begins. Clinical Study report will be made available a year after the study has completed recruitment (November 2023)Data collection is scheduled to end in November 2022 so we anticipate the data will be deposited in November 2023. Additional precautions will be taken to maintain anonymity, such as the removal of birthdates. All documentation will be freely available for download by third parties. Requests for access to the dataset will be made via DataCompass. A committee consisting of members of the Trial Management Group will review requests within 30 days of application. Any scientifically valid request will be granted access to the dataset
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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