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Trial record 2 of 2 for:    12588571 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT01153568
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
John F. Aloia, MD, Winthrop University Hospital

Tracking Information
First Submitted Date  ICMJE June 28, 2010
First Posted Date  ICMJE June 30, 2010
Last Update Posted Date October 3, 2018
Study Start Date  ICMJE August 2010
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2010)
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 ]
2. To determine whether such supplementation will inhibit the decline in physical performance with aging.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01153568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2010)
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 ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D and Osteoporosis Prevention in Elderly African American Women
Official Title  ICMJE 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
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Determine Effect of Vitamin D on Bone Health in Elderly African American Women
Intervention  ICMJE
  • Dietary Supplement: Vitamin D 3
    Patients will bew given a single capsule to take once daily
  • Other: placebo
    placebo tablets
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    placebo
    Intervention: Other: placebo
  • Experimental: Vitamin D 3
    Vitamin D3 will be available in doses of 60, 90, 120, and 150 µg
    Intervention: Dietary Supplement: Vitamin D 3
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2016)
260
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2010)
250
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, hematologic 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01153568
Other Study ID Numbers  ICMJE 08032
R01AG032440 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John F. Aloia, MD, Winthrop University Hospital
Study Sponsor  ICMJE Winthrop University Hospital
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: John F. Aloia, MD Winthrop University Hospital
PRS Account Winthrop University Hospital
Verification Date June 2018

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