In order to study the effect of providing vitamin D3 and calcium for children who have HIV, we will recruit 840 children, who meet the recruitment criteria, at Harare Children's Hospital in Harare, Zimbabwe and at the University Teaching Hospital in Lusaka, Zambia. For the children and adolescents who are potentially eligible, our clinical team will approach and inform their caregivers about the study. If both caregivers and children/adolescents themselves provide written consent and assent, they will either be given a daily supplementation of calcium (500mg) and a weekly high-dose of vitamin D3 (20,000IU) or a placebo, both for 48 weeks.
MEASUREMENT
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We will assess vitamin D status using tandem mass spectrometry at baseline, after 48 and 96 weeks post-enrolment.
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We will determine calcium levels using chemiluminescence immunoassays, at baseline, after 48 and 96 weeks post-enrolment.
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We will study the species diversity and composition of the patient's microbiome using RNA sequencing from patient stool samples.
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We will evaluate patient bone density using quantitative computed tomography, at baseline, after 48 and 96 weeks post-enrolment. This can only happen in Zimbabwe because Zambia, unfortunately, does not have a P-QCT machine.
Primary Objective
Our primary objective is to investigate the efficacy of a weekly supplementation of high-dose vitamin D3 (cholecalciferol) plus a daily supplementation of calcium carbonate for 48 weeks on musculoskeletal health and immune-regulation in peripubertal children and adolescents living with HIV aged between 11-19 years in Zambia and Zimbabwe.
Secondary Objectives
Additionally, we seek to investigate the intervention's effect on muscle mass and strength and to determine the sustainability of the intervention's effects by performing a follow-up at 96 weeks after the supplementation period.
To achieve our primary and secondary outcomes, we have d​ivided the study into eight workpackages:
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Clinical Trial Design and Conduct
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Data Management and Analysis
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Networking, Communication & Dissemination
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Mechanistic Studies of Bone Metabolism
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Immunology Studies
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Microbiome Studies
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Capacity Strengthening & Training
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Project Management
TRIAL
WORK PACKAGES
CONTACT VITALITY
