Vitamin D HIV Study on Postmenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: Placebo; Drug: Vitamin Supplements; Drug: Vitamin D3

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 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 Names: Vitamin supplementation; Drug: Vitamin D3; 2000 mg QD; Other Names: cholecalciferol-D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Areal Change in Bone Mineral Density (aBMD)	To evaluate the change in areal BMD (aBMD) at the total hip (TH)	Baseline,12 months
Change in Volumetric Bone Mineral Density (vBMD)	To evaluate the change in volumetric BMD (VBMD) at the Tibia	Baseline, 12 months
Change in Vitamin D Levels	To evaluate the change in vitamin D levels with supplementation	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)	12 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Elizabeth Shane, MD, Columbia University; Study Director: Michael Yin, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: June 15, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (Estimate): June 17, 2011

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Vitamin D; HIV; Postmenopausal women
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins
• Other Study ID Numbers: AAAF2194; 2R01AI065200-06A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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