Preventing Bone Loss Among Chinese Patients With HIV on ART
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|ClinicalTrials.gov Identifier: NCT03598556|
Recruitment Status : Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Osteoporosis Bone Loss||Dietary Supplement: Vitamin D3 Other: Placebo||Not Applicable|
Studies among adult and pediatric populations have suggested vitamin D supplementation may be efficacious for mitigating the bone loss seen with tenofovir-based antiretroviral therapy (ART). Because patients with HIV face significant pill burden, competing priorities and health care associated costs, we seek to explore a pragmatic approach to prevention. The investigators propose a randomized controlled, double-blind, placebo intervention trial to assess the efficacy, tolerability, and safety of an intermittent high-dose vitamin D3 supplementation regimen given quarterly at the point of care for adult patients receiving free ART through the China National Free AIDS Treatment Program. The period of supplementation will be limited to the first 48 weeks after treatment initiation when ART-associated bone loss is most pronounced. This will be followed by supplementation of all participants with vitamin D3 from 48 to 96 weeks to compare the impact of early vitamin D3 supplementation (at ART initiation) versus late vitamin D3 supplementation (at 48 weeks) on change in BMD.
Furthermore, despite the rapid rise in access to ART in China, infrastructure to diagnose and manage osteoporosis is not always easily accessible for patients with HIV in China due to limited availability of dual-energy x-ray absorptiometry (DXA), the gold standard for BMD measurement. Therefore, the current proposal also seeks to bridge this gap by exploring the potential applications of quantitative ultrasound (QUS), a portable and low-cost method of assessing BMD that has been demonstrated to reliably predict fracture, in HIV care settings.
A total of 400 treatment-naïve Chinese adults diagnosed with HIV from 3 study sites in Beijing will be enrolled and followed with serial DXA exams to evaluate the primary aim. These 400 patients plus another 200 participants from 3 additional study sites from Fuzhou, Shenzhen, and Guangxi province, will be evaluated with serial QUS ultrasound examinations for the secondary aims. Serum and urine samples will be collected and stored at pre-specified time points.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Strategies for the Prevention of Bone Loss Among Patients With HIV on Antiretroviral Therapy in China|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Vitamin D3 Supplementation Arm
This arm will receive 180,000IU vitamin D3 every 3 months from baseline through week 96.
Dietary Supplement: Vitamin D3
180,000IU Vitamin D3 oral emulsion
Placebo Comparator: Placebo Arm
This arm will receive placebo every 3 months from baseline through week 48, followed by 180,000IU vitamin D3 every 3 months from week 48 through week 96.
- Change in Bone Mineral Density (BMD) [ Time Frame: Baseline to week 48 ]In the three sites in Beijing (N=400), compare percent change in BMD at the lumbar spine and total hip, as measured by dual-energy x-ray absorptiometry (DXA) at week 48.
- Immediate vs. Delayed Vitamin D3 Supplementation [ Time Frame: Weeks 48 to 96 ]In the three sites in Beijing (N=400), from 48 to 96 weeks, switch the placebo arm to vitamin D3 supplementation to compare percent change in BMD at 96 weeks between patients who initiated vitamin D3 supplementation at the start of ART versus those who initiated vitamin D3 after 1 year of ART.
- Change in Quantitative Ultrasound (QUS) Measures [ Time Frame: Baseline to 96 weeks ]In all six study sites (N=600), evaluate percent change in SOS and BUA over 48 weeks in the vitamin D treatment group compared with placebo, as measured by QUS. Further, evaluate the ability of QUS to independently identify the same group of patients at greatest risk for severe bone loss, as compared with risk stratification using DXA.
- Change in Biochemical Markers [ Time Frame: Baseline to 96 weeks ]To measure the effect of the proposed intervention on markers of vitamin D and bone metabolism, inflammation and HIV disease status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598556
|Beijing Ditan Hospital|
|Beijing, Beijing, China|
|Beijing Youan Hospital|
|Beijing, Beijing, China|
|Peking Union Medical College Hospital|
|Beijing, Beijing, China|
|Fuzhou Infectious Diseases Hospital|
|Fuzhou, Fujian, China|
|Shenzhen Third Hospital|
|Shenzhen, Guangdong, China|
|China, Guangxi Autonomous Region|
|Liuzhou, Guangxi Autonomous Region, China|
|Principal Investigator:||Taisheng Li, MD, PhD||Peking Union Medical College Hospital|