HIVPhase 1/2NCT01375010

Vitamin D HIV Study on Postmenopausal Women

A Phase 1/2 study testing Vitamin D3 and Vitamin Supplements in people with HIV, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 70 years, women only
Conditions the study is for: HIV
What is being tested?: Vitamin D3 and Vitamin Supplements
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 85 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Feb 2016
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV+ African American and Latina postmenopausal women, aged 40-70, who meet the standard definition of menopause:
If 50 years old or older then amenorrhea for > 1year. If age 40 to 49 then amenorrhea for over a year and and Follicle-Stimulating Hormone (FSH) level of equal to or greater than 20 mIU/ml; as some amenorrheic chronically ill women may have hypothalamic dysfunction and low FSH values, if FSH is 10 to 19, and the serum estradiol level is consistent with menopause less than or equal to 30pg/ml, she will be determined to be postmenopausal.
On stable antiretroviral therapy (ART) for >2 years
Undetectable HIV RNA (viral load) at least 2 times over the past year (RNA <400)

Who cannot join

Metabolic bone disease (Paget's disease, clinical osteomalacia, primary hyperparathyroidism, hypercalcemia)
Multiple myeloma, solid tumors with metastases;
Endocrinopathy (hyperthyroidism, untreated hypothyroidism, Cushing's syndrome, prolactin-secreting pituitary adenoma)
Renal insufficiency (serum creatinine above 1.5 mg/dl)
Liver disease (AST, ALT, bilirubin, total alkaline phosphatase activity > twice upper normal limit);
Intestinal disorders (celiac disease, pancreatic insufficiency, Crohn's disease, ulcerative colitis)

Show all 14Show fewer

Current use of glucocorticoids, anticonvulsants, anticoagulants, diuretics, methotrexate;
Current or past use of drug therapies for osteoporosis (raloxifene, bisphosphonates, calcitonin, PTH). Women on estrogen are excluded. Past estrogen use is permitted if discontinued >1 year before enrollment.
If there is a history of a low trauma fracture, a T score < -3 or a prevalent vertebral fracture on Instant Vertebral Assessment™ (IVA), subjects will be referred for osteoporosis treatment as appropriate.
Severe vitamin D deficiency (25-OHD level <10 ng/ml) or normal baseline serum vitamin D (25-OHD >32 ng/ml). Subjects with severe vitamin D deficiency may be referred to our sub-study, if all other inclusion/exclusion criteria are met.
Hypercalcemia or history of calcium-containing kidney stones
Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations
Current imprisonment or voluntary incarceration in a medical facility for psychiatric illness
Any condition that, in the opinion of the site investigator, would compromised the subject's ability to participate in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Medical Center
New York, New York, 10032

Other trials in United States

About this study

Official title: The Effect of Vitamin D Repletion on Postmenopausal Women With HIV

The purpose of this study is to determine the effects of vitamin D on measures of bone health and immune function in HIV infected postmenopausal women. The investigators prior research with this population revealed that low vitamin D levels are very common. Prior research with this population also revealed that Vitamin D is necessary for the body to absorb calcium and is important for the health of the bones. When vitamin D levels are low, there are increased risks of bone loss, muscle weakness, falls and fractures. Low levels of vitamin D have also been associated with impaired immune function. This study will help us learn whether two different doses of vitamin D will improve bone health and immune function.

Read the detailed description

The purpose of this study is to determine the effects of vitamin D repletion on rates of bone loss and indices of immune function in HIV+ postmenopausal women. Lower baseline serum Vitamin D levels, as assessed by measuring serum 25-hydroxyvitamin D (25-OHD) were associated with a trend toward more bone loss. In addition, the investigators found that despite providing supplements that contained approximately 600 IU vitamin D, serum 25-OHD did not increase during the first year. Provision of adequate calcium and vitamin D is the cornerstone of effective prevention and therapy of osteoporosis. HIV-infected patients may be at increased risk of having vitamin D deficiency because they take several medications that may interfere with vitamin D action. Therefore, the investigators will recruit 100 HIV infected postmenopausal women for this study who are on a stable antiretroviral therapy (ART) regimen and randomize them to receive 1000 or 3000 IU of vitamin D daily. The subjects will be followed closely for one year to monitor compliance and changes in bone health and immune function.

Conditions: HIV
Being tested: Vitamin D3, Placebo, Vitamin Supplements
Keywords: HIV, Postmenopausal women, Vitamin D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin D3Drug
Also called cholecalciferol-D3
2000 mg QD
PlaceboOther
Also called Placebo capsule
An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin SupplementsDrug
Also called Vitamin supplementation
Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).

Study groups in NCT01375010
Study group	Role	What they receive
Group A	Placebo comparator	Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU. Receives: Other: Placebo; Drug: Vitamin Supplements
Group B	Experimental	2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU. Receives: Drug: Vitamin D3; Drug: Vitamin Supplements

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Bone Mineral Density (BMD)
Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months
Measured: Baseline, 12 months

Secondary outcomes (4)

Areal Change in Bone Mineral Density (aBMD)
To evaluate the change in areal BMD (aBMD) at the total hip (TH)
Measured: Baseline,12 months
Change in Volumetric Bone Mineral Density (vBMD)
To evaluate the change in volumetric BMD (VBMD) at the Tibia
Measured: Baseline, 12 months
Change in Vitamin D Levels
To evaluate the change in vitamin D levels with supplementation
Measured: 12 months
Change in Biochemical Markers
To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation. (PTH)
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Feb 2016

First posted17 Jun 2011 (estimated)
Study startJan 2011
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01375010
Sponsor's protocol ID: AAAF2194
Other IDs: 2R01AI065200-06A1
Status last verified: Mar 2019
First submitted: 15 Jun 2011
Last updated: 7 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Vitamin D Repletion on Postmenopausal Women With HIV
ClinicalTrials.gov ID: NCT01375010
Acronym / sponsor ID: AAAF2194
Conditions: HIV
Keywords: HIV, Postmenopausal women, Vitamin D
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Jan 2011 (actual)
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 17 Jun 2011 (estimated)
Results: Posted 7 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A	Placebo comparator	Other: Placebo, Drug: Vitamin SupplementsPlacebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Group B	Experimental	Drug: Vitamin D3, Drug: Vitamin Supplements2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.

Who may qualify

Ages: 40 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

HIV+ African American and Latina postmenopausal women, aged 40-70, who meet the standard definition of menopause:
If 50 years old or older then amenorrhea for > 1year. If age 40 to 49 then amenorrhea for over a year and and Follicle-Stimulating Hormone (FSH) level of equal to or greater than 20 mIU/ml; as some amenorrheic chronically ill women may have hypothalamic dysfunction and low FSH values, if FSH is 10 to 19, and the serum estradiol level is consistent with menopause less than or equal to 30pg/ml, she will be determined to be postmenopausal.
On stable antiretroviral therapy (ART) for >2 years
Undetectable HIV RNA (viral load) at least 2 times over the past year (RNA <400)

Key exclusion criteria (14 listed)

Metabolic bone disease (Paget's disease, clinical osteomalacia, primary hyperparathyroidism, hypercalcemia)
Multiple myeloma, solid tumors with metastases;
Endocrinopathy (hyperthyroidism, untreated hypothyroidism, Cushing's syndrome, prolactin-secreting pituitary adenoma)
Renal insufficiency (serum creatinine above 1.5 mg/dl)
Liver disease (AST, ALT, bilirubin, total alkaline phosphatase activity > twice upper normal limit);

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 D3Also: cholecalciferol-D32000 mg QD	Drug	Group B
PlaceboAlso: Placebo capsuleAn inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.	Other	Group A
Vitamin SupplementsAlso: Vitamin supplementationSpecially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).	Drug	Group A, Group B

Primary outcome

Change in Bone Mineral Density (BMD)
Time frame: Baseline, 12 months
Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months

4 secondary outcomes

Areal Change in Bone Mineral Density (aBMD)
Time frame: Baseline,12 months
Change in Volumetric Bone Mineral Density (vBMD)
Time frame: Baseline, 12 months
Change in Vitamin D Levels
Time frame: 12 months
Change in Biochemical Markers
Time frame: 12 months

Results and safety

Results posted to the registry on 7 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	43	31
Group B	42	38

Primary outcome: Change in Bone Mineral Density (BMD)

Time frame: Baseline, 12 months. Mean (Standard Deviation). Unit: percentage change

Measure	Group A n = 31	Group B n = 38
Value	0.4 (4.4)	-0.8 (4.6)

Population analysed: A complete case approach was utilized for outcome in participants with BMD data at 12 months (n=69).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	1 of 43 (2.3%)	6 of 43 (14%)	0 of 43
Group B	1 of 42 (2.4%)	5 of 42 (11.9%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

Elizabeth Shane, MD principal investigator

Columbia University

Michael Yin, MD study director

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vitamin D3 and Vitamin Supplements in people with HIV, run by Columbia University at 1 site in United States.

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 4 inclusion and 14 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: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01375010.

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 Mar 2019.