Vitamin D HIV Study on Postmenopausal Women

• ClinicalTrials.gov Identifier: NCT01375010
• Recruitment Status: Completed
• First Posted: June 17, 2011
• Results First Posted: March 7, 2019
• Last Update Posted: March 7, 2019
• Sponsor: Columbia University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Elizabeth Shane, Columbia University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
HIV	Drug: Vitamin D3; Other: Placebo; Drug: Vitamin Supplements	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Vitamin D Repletion on Postmenopausal Women With HIV
• Actual Study Start Date: January 2011
• Actual Primary Completion Date: February 2016
• Actual Study Completion Date: February 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Group A; 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.	Other: Placebo; An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.; Other Name: Placebo capsule; Drug: Vitamin Supplements; 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).; Other Name: Vitamin supplementation
Experimental: Group B; 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.	Drug: Vitamin D3; 2000 mg QD; Other Name: cholecalciferol-D3; Drug: Vitamin Supplements; 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).; Other Name: Vitamin supplementation

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Elizabeth Shane, MD; Columbia University
• Study Director: Michael Yin, MD; Columbia University

More Information

• Responsible Party: Elizabeth Shane, Professor of Medicine, Endocrinology, Columbia University
• ClinicalTrials.gov Identifier: NCT01375010 History of Changes
• Other Study ID Numbers: AAAF2194; 2R01AI065200-06A1 ( U.S. NIH Grant/Contract )
• First Posted: June 17, 2011
• Results First Posted: March 7, 2019
• Last Update Posted: March 7, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Elizabeth Shane, Columbia University:

HIV; Postmenopausal women; Vitamin D

Additional relevant MeSH terms:

Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents