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Preventing Bone Loss Among Chinese Patients With HIV on ART

NCT03598556 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2020-07-07

No results posted yet for this study

Summary

The major goal of this study will be to conduct a randomized, double-blind, placebo-controlled, clinical trial of intermittent high-dose vitamin D3 supplementation (180,000IU) given at the point of care (every 3 months) after initiation of ART with tenofovir/ lamivudine/ efavirenz to compare its ability to mitigate reductions in bone mineral density over 12 months compared to placebo.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

180,000IU Vitamin D3 oral emulsion

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Beijing YouAn Hospital

    collaborator OTHER

  • Beijing Ditan Hospital

    collaborator OTHER

  • Guangxi Autonomous Region Longtan Hospital

    collaborator UNKNOWN

  • Fuzhou Infectious Diseases Hospital

    collaborator UNKNOWN

  • Shenzhen Third People's Hospital

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Taisheng Li, MD, PhD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598556 on ClinicalTrials.gov