HIV/AIDSNCT03598556
Preventing Bone Loss Among Chinese Patients With HIV on ART
A study testing Vitamin D3 in people with HIV/AIDS and Osteoporosis, run by Peking Union Medical College Hospital at 6 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV/AIDS, Osteoporosis, Bone Loss
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jun 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Willingness and availability to engage in study activities for the duration of the study
- Documented HIV-1 infection (confirmed by Western blot)
- ART naïve at the time of enrollment
- Eligible to initiate ART (TDF/3TC/EFV) within 1 month
- Ability to take oral medication and be willing to adhere to the mediation regimen
- For females of reproductive potential: use of highly effective contraception
Who cannot join
- Pregnancy or breastfeeding
- AIDS-defining illness within 2 weeks of entry
- Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
- Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
- Patients with a history of injection drug usage
- Known history of osteoporosis, osteoporotic fracture, or other metabolic/inherited bone disorder
Show all 16Show fewer
- History of treatment with prescription therapies for osteoporosis (for example: bisphosphonates, denosumab, teriparatide, selective estrogen receptor modifying agents, active forms of vitamin D).
- Unwillingness to discontinue previous vitamin D supplementation, if any, at time of enrollment
- Rheumatoid arthritis
- Malabsorption or inflammatory bowel disease
- Hyperparathyroidism, hypercalcemia, or hypocalcemia
- History of kidney stones
- Poorly controlled thyroid disease
- History of neuromuscular disorder/movement disorder, stroke or seizures
- History of significant neurocognitive disorders (including mental health conditions or dementia)
- Glucocorticoids, estrogen, testosterone, or anticonvulsant use within the past six months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Ditan Hospital
Beijing, Beijing Municipality
Beijing Youan Hospital
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Fuzhou Infectious Diseases Hospital
Fuzhou, Fujian
Longtan Hospital
Liuzhou, Guangxi Autonomous Region
Shenzhen Third Hospital
Shenzhen, Guangdong
About this study
Official title: Strategies for the Prevention of Bone Loss Among Patients With HIV on Antiretroviral Therapy in China
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.
Read the detailed description
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.
- Conditions
- HIV/AIDS, Osteoporosis, Bone Loss
- Being tested
- Vitamin D3, Placebo
- Keywords
- China, Anti-retroviral Therapy, Vitamin D, Tenofovir, Efavirenz, Lamivudine
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
180,000IU Vitamin D3 oral emulsion
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 Supplementation Arm | Experimental | This arm will receive 180,000IU vitamin D3 every 3 months from baseline through week 96. Receives: Dietary Supplement: Vitamin D3 |
| Placebo Arm | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Mineral Density (BMD)
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.
Measured: Baseline to week 48
Secondary outcomes (3)
Immediate vs. Delayed Vitamin D3 Supplementation
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.
Measured: Weeks 48 to 96
Change in Quantitative Ultrasound (QUS) Measures
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.
Measured: Baseline to 96 weeks
Change in Biochemical Markers
To measure the effect of the proposed intervention on markers of vitamin D and bone metabolism, inflammation and HIV disease status.
Measured: Baseline to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jun 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing YouAn Hospital, Beijing Ditan Hospital, Guangxi Autonomous Region Longtan Hospital, Fuzhou Infectious Diseases Hospital, Shenzhen Third People's Hospital, Yale University
- Responsible party
- Principal investigator, LI Taisheng, Peking Union Medical College Hospital
- Investigators
- Taisheng Li, MD, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598556
- Sponsor's protocol ID
- CACT 1807
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for the Prevention of Bone Loss Among Patients With HIV on Antiretroviral Therapy in China
- ClinicalTrials.gov ID
- NCT03598556
- Acronym / sponsor ID
- CACT 1807
- Conditions
- HIV/AIDS, Osteoporosis, Bone Loss
- Keywords
- China, Anti-retroviral Therapy, Vitamin D, Tenofovir, Efavirenz, Lamivudine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing YouAn Hospital, Beijing Ditan Hospital, Guangxi Autonomous Region Longtan Hospital, Fuzhou Infectious Diseases Hospital, Shenzhen Third People's Hospital, Yale University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 Supplementation Arm | Experimental | Dietary Supplement: Vitamin D3This arm will receive 180,000IU vitamin D3 every 3 months from baseline through week 96. |
| Placebo Arm | Placebo comparator | Other: PlaceboThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Willingness and availability to engage in study activities for the duration of the study
- Documented HIV-1 infection (confirmed by Western blot)
- ART naïve at the time of enrollment
- Eligible to initiate ART (TDF/3TC/EFV) within 1 month
Key exclusion criteria (16 listed)
- Pregnancy or breastfeeding
- AIDS-defining illness within 2 weeks of entry
- Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
- Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
- Patients with a history of injection drug usage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3180,000IU Vitamin D3 oral emulsion | Dietary supplement | Vitamin D3 Supplementation Arm |
| PlaceboPlacebo | Other | Placebo Arm |
Primary outcome
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.
3 secondary outcomes
Immediate vs. Delayed Vitamin D3 Supplementation
Time frame: Weeks 48 to 96
Change in Quantitative Ultrasound (QUS) Measures
Time frame: Baseline to 96 weeks
Change in Biochemical Markers
Time frame: Baseline to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taisheng Li, MD, PhD principal investigator
Peking Union Medical College Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with HIV/AIDS and Osteoporosis, run by Peking Union Medical College Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bone Mineral Density (BMD) (time frame: Baseline to week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.