Vitamin D and Osteoporosis Prevention in Elderly African American Women (NIHD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Winthrop University Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John F. Aloia, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01153568
First received: June 28, 2010
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

Vitamin D is a hormone that is produced when sunlight is absorbed by the skin. Vitamin D insufficiency has been recognized as a problem in areas where sun exposure is limited, especially in the wintertime. In addition, the more pigmented the skin is, the less capable it is of utilizing sunlight to make vitamin D. Vitamin D plays an important role in helping the body absorb calcium and in building strong bones. It has also been shown to improve muscle function in the elderly. As we get older, our vitamin D levels in the blood go down and this may increase the risk for falls and fractures. If we can improve vitamin D status as we age, we may be able to improve muscle strength and decrease the risk of falls and fractures.


Condition Intervention Phase
Determining if Vitamin D Can Decrease Bone Loss and Inhibit the Decline Physical Performance in Elderly African American Women.
Dietary Supplement: Vitamin D 3
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D and Osteoporosis Prevention in Elderly African American Women: A 4-year Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Vitamin D Status in Elderly African American Women

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • 1. To determine if vitamin D supplementation sufficient to raise serum 25(OH)D levels above 75 nmol/L (30 ng/mL) for four years will reduce bone density loss, markers of bone turnover, and serum PTH in elderly black women [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    2. To determine whether such supplementation will inhibit the decline in physical performance with aging.


Secondary Outcome Measures:
  • To evaluate the harms of vitamin D intakes that raise 25(OH)D levels above 75 nmol/L for four years in a calcium sufficient population [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    This research will fill an important gap in knowledge about the potential benefit of vitamin D supplementation in elderly black women. While many experts agree that vitamin D intake should be increased in the elderly, few pertinent studies have included black participants, who represent a vulnerable population due to their low serum 25(OH)D. If vitamin D supplementation proves to be beneficial in this minority group, that would suggest the appropriateness of intake recommendations similar to those proposed for white populations.


Estimated Enrollment: 250
Study Start Date: August 2010
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: placebo
placebo tablets
Experimental: Vitamin D 3
Vitamin D3 will be available in doses of 60, 90, 120, and 150 µg
Dietary Supplement: Vitamin D 3
Patients will bew given a single capsule to take once daily

Detailed Description:

The long-term goal of this project is to develop strategies for the prevention of osteoporotic fractures in African Americans. Most intervention studies have excluded African Americans because of the erroneous belief that osteoporosis is not a major health problem in this population. In fact, the incidence rate of hip fracture in blacks is 50% of the rate in whites. Since longevity is increasing in the black population, osteoporotic fractures will become an even greater problem for this ethnic minority in the future. Furthermore, morbidity and mortality from osteoporotic fractures is greater in blacks. The elderly require higher intake of vitamin D to prevent bone loss resulting from secondary hyperparathyroidism. Calcium with sufficient vitamin D supplementation may decrease fractures in elderly white populations as a result of reduction in bone loss and falls (improved physical performance). The only fracture intervention study to include African Americans—the Women's Health Initiative—used an inadequate dose of vitamin D (400 IU), a dose unlikely to achieve the vitamin D status proposed by U.S. experts: serum 25 hydroxyvitamin D [25(OH)D] concentration above 75 nmol/L. No calcium/vitamin D intervention studies on fall prevention or physical performance have included African Americans.

As a result of increased skin pigmentation, blacks synthesize less vitamin D from sun exposure. As a result, serum 25(OH)D levels are often in the "insufficient" range. This is accompanied by secondary hyperparathyroidism, but adult blacks have a relative skeletal resistance to PTH, so that they have lower bone turnover. They also have more efficient renal conservation of calcium starting in childhood. Addition of vitamin D3 to a calcium-sufficient African American postmenopausal population does not prevent bone loss. The calcium/vitamin D requirements of black adults may be lower than white adults through midlife. However, the elderly require more vitamin D to produce the higher 25(OH)D levels required to overcome the hyperparathyroidism associated with aging. The skeleton of elderly African Americans appears to be susceptible to the increasing parathyroid hormone levels of old age. Bone loss accelerates and bone turnover markers increase in elderly African Americans just as in whites. The specific aims of this project are to determine if dietary supplementation with calcium/vitamin D will safely reduce bone loss and bone turnover and improve physical performance in elderly African Americans. We will enroll 250 African American women in a four-year vitamin D3 intervention trial where serum 25(OH)D will be maintained at an optimum level above 75 nmol/L. Adequate calcium intake will be ensured. Functional markers of vitamin D including bone density, serum PTH, and bone turnover will be measured. The NIH Conference on Vitamin D and Health in the 21st Century, September 5-6, 2007 concluded that research in this population is a high priority.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ambulatory women older than 60 years of age. Self declared as African Americans.
  2. 20 nmol/L < serum 25(OH)D level < 65 nmol/L.
  3. Willingness to take study drug and participate for four years in the trial.
  4. Willingness to refrain from the use of self-administered supplements during the trial.

Exclusion Criteria:

  1. Serum 25(OH)D levels ≤ 20 nmol/L or ≥ 65 nmol/L.
  2. BMD total hip below - 2.5 standard deviation (using NHANES III adult young white men and women as the point of reference) or history of osteoporotic fracture.
  3. Moderate to severe fracture in one or more vertebrae by Instant Vertebral Assessment on DXA.
  4. Treatment with HRT, SERMS, calcitonin, PTH, androgens, bisphosphonates, phosphate or anabolic steroids during 6 months prior to entry.
  5. Use of systemic corticosteroids (oral or IV) within the last year at an average dose of greater than 5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening.
  6. Hypercalcemia (serum calcium > 10.6 mg (dl) or history of primary hyperparathyroidism.
  7. History of chronic liver disease, chronic renal insufficiency, Parkinson's, metabolic bone disease, hema-tologic tumors, rheumatologic disease requiring steroids, malabsorption or new diagnosis or active treat-ment of cancer 12 months prior to inclusion.
  8. Use of medications that influence bone metabolism (e.g. anticonvulsants).
  9. Significant deviation from normal in either: history, physical examination or laboratory tests as evaluated by the Principle Investigator. Participants with a history of hypercalciuria, nephrolithiasis and active sarcoidosis will also be excluded.
  10. Participation in another investigational trial 30 days prior to screening.
  11. Spinal disease that affects interpretation of bone densitometry like scoliosis with a Cobb angle greater than 15o, history of surgery at lumbosacral spine.
  12. Bilateral hip replacement.
  13. Currently smoking more than 10 cigarettes daily.
  14. Body width on DXA > 25 cm.
  15. Patients who are deemed unsafe to perform muscular function testing as evaluated by the investigator.

    ---------- Study participants should live close to the study site, as this study requires multiple visits over a four year period.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153568

Contacts
Contact: Jane S. Greensher, R.N. CCRC 516 663 2772 Jmoore@winthrop.org
Contact: Catherine B New 516 663 3380 Cnew@winthrop.org

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: John F. Aloia, MD    516-663-2442    Jaloia@winthrop.org   
Contact: Mageda Mikhail, MD    516 663 4800    MMikhail@winthrop.org   
Principal Investigator: John F. Aloia, MD         
Sub-Investigator: Mageda Mikhail, MD         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: John F. Aloia, MD Winthrop University Hospital
  More Information

Additional Information:
Publications:

Responsible Party: John F. Aloia, MD, Chief Academic Affairs, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01153568     History of Changes
Other Study ID Numbers: 08032, R01AG032440
Study First Received: June 28, 2010
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Vitamin D, osteoporosis, African American Women

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 27, 2014