Vitamin D HIV Study on Postmenopausal Women

NCT01375010 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: AAAF21942R01AI065200-06A1
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Postmenopausal women; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Areal Change in Bone Mineral Density (aBMD)

  Baseline,12 months

• Change in Volumetric Bone Mineral Density (vBMD)

  Baseline, 12 months

• Change in Vitamin D Levels

  12 months

• Change in Biochemical Markers

  12 months

Study Arms (2)

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.

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.

Drug: Vitamin D3; Drug: Vitamin Supplements

Interventions

Vitamin D3 DRUG

2000 mg QD

Also known as: cholecalciferol-D3

Group B

Placebo OTHER

An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.

Also known as: Placebo capsule

Group A

Vitamin Supplements DRUG

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).

Also known as: Vitamin supplementation

Group A; Group B

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Cholecalciferol; Geritol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Elizabeth Shane, MD
• Organization: Columbia University

es54@cumc.columbia.edu

212-305-6289

Study Officials

• Elizabeth Shane, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Michael Yin, MD

  Columbia University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Endocrinology

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 17, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 7, 2019
• Results First Posted: March 7, 2019

Record last verified: 2019-03

Locations

US (1)