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Vitamin D HIV Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elizabeth Shane, Columbia University
ClinicalTrials.gov Identifier:
NCT01375010
First received: June 15, 2011
Last updated: August 20, 2014
Last verified: August 2014

June 15, 2011
August 20, 2014
January 2011
December 2015   (final data collection date for primary outcome measure)
Change in Bone Mineral Density (BMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months
Same as current
Complete list of historical versions of study NCT01375010 on ClinicalTrials.gov Archive Site
  • Areal Change in Bone Mineral Density (aBMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the change in areal BMD (aBMD) at the total hip (TH), femoral neck (FN), and distal radius (DR);
  • Change in Volumetric Bone Mineral Density (vBMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the change in volumetric BMD (VBMD) at the radius, tibia, hips and lumbar spine
  • Change in Vitamin D levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the change in vitamin D levels with supplementation
  • Change in Biochemical markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation.
  • Change in Immune function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect of vitamin D supplementation on biochemical markers of immune function
  • Change in Muscle measures and frailty [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect of vitamin D supplementation on muscle strength.
  • Change in Biochemical Markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of inflammation.
  • Change in Muscle measures and frailty [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect of vitamin D supplementation on functional muscle performance.
  • Areal Change in Bone Mineral Density (aBMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the change in areal BMD (aBMD) at the total hip (TH), femoral neck (FN), and distal radius (DR);
  • Volumetric Bone Mineral Density (vBMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the change in volumetric BMD (VBMD) at the radius, tibia, hips and lumbar spine
  • Change in Vitamin D levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the change in vitamin D levels with supplementation
  • Biochemical markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation.
  • Immune function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect of vitamin D supplementation on biochemical markers of immune function
  • Muscle measures and frailty [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect of vitamin D supplementation on muscle strength.
  • Biochemical Markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of inflammation.
  • Muscle measures and frailty [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect of vitamin D supplementation on functional muscle performance.
Not Provided
Not Provided
 
Vitamin D HIV Study
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV
  • Drug: Vitamin D3
    All subjects will be provided with supplements that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 and will be instructed to take one twice daily with breakfast and dinner. Participants will then be block randomized in a 1:1 ratio with randomly varying block sizes of 2, 4 or 6 to 2000 IU vitamin D3 (Group A) or placebo (Group B). Group A will receive a total of 3000 IU/day, the dose and Group B will receive 1000 IU/day.
  • Drug: Placebo
    Participants will then be block randomized in a 1:1 ratio with randomly varying block sizes of 2, 4 or 6 to 2000 IU vitamin D3 (Group A) or placebo (Group B). Group A will receive a total of 3000 IU/day, the dose and Group B will receive 1000 IU/day.
  • Experimental: Group A
    1000 IU vitamin D + placebo capsule = 1000 IU/day of vitamin D
    Interventions:
    • Drug: Vitamin D3
    • Drug: Placebo
  • Experimental: Group B
    1000 IU vitamin D + 2000 IU vitamin D = 3000 IU/day of vitamin D
    Intervention: Drug: Vitamin D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • 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
Female
40 Years to 70 Years
No
Contact: Michael Yin, MD mty4@columbia.edu
Contact: Mariana Bucovsky 2123057225 mb3523@columbia.edu
United States
 
NCT01375010
AAAF2194, 2R01AI065200-06A1
Yes
Elizabeth Shane, Columbia University
Columbia University
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Elizabeth Shane, MD Columbia University
Study Director: Michael Yin, MD Columbia University
Columbia University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP