Vitamin D and Osteoporosis Prevention in Elderly African American Women

NCT01153568 | Completed Phase 3 DMC

• 2 other identifiers: 08032R01AG032440
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Determine Effect of Vitamin D on Bone Health in Elderly African American Women

Keywords

Vitamin D; osteoporosis; african american women

Outcome Measures

Primary Outcomes (1)

• 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

  2\. To determine whether such supplementation will inhibit the decline in physical performance with aging.

  4 years

Secondary Outcomes (1)

• 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

  4 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo

Other: placebo

Vitamin D 3

EXPERIMENTAL

Vitamin D3 will be available in doses of 60, 90, 120, and 150 µg

Dietary Supplement: Vitamin D 3

Interventions

Vitamin D 3 DIETARY_SUPPLEMENT

Patients will bew given a single capsule to take once daily

Vitamin D 3

placebo OTHER

placebo tablets

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Serum 25(OH)D levels ≤ 20 nmol/L or ≥ 65 nmol/L.
• 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.
• Moderate to severe fracture in one or more vertebrae by Instant Vertebral Assessment on DXA.
• Treatment with HRT, SERMS, calcitonin, PTH, androgens, bisphosphonates, phosphate or anabolic steroids during 6 months prior to entry.
• 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.
• Hypercalcemia (serum calcium \> 10.6 mg (dl) or history of primary hyperparathyroidism.
• Use of medications that influence bone metabolism (e.g. anticonvulsants).
• 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.
• Participation in another investigational trial 30 days prior to screening.
• Spinal disease that affects interpretation of bone densitometry like scoliosis with a Cobb angle greater than 15o, history of surgery at lumbosacral spine.
• Bilateral hip replacement.
• Currently smoking more than 10 cigarettes daily.
• Body width on DXA \> 25 cm.
• 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.

Sponsors & Collaborators

• Winthrop University Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related Publications (19)

• Bischoff-Ferrari HA, Giovannucci E, Willett WC, Dietrich T, Dawson-Hughes B. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr. 2006 Jul;84(1):18-28. doi: 10.1093/ajcn/84.1.18.

  PMID: 16825677 BACKGROUND

• Aloia JF, Vaswani A, Yeh JK, Flaster E. Risk for osteoporosis in black women. Calcif Tissue Int. 1996 Dec;59(6):415-23. doi: 10.1007/BF00369203.

  PMID: 8939764 BACKGROUND

• Cauley JA, Lui LY, Stone KL, Hillier TA, Zmuda JM, Hochberg M, Beck TJ, Ensrud KE. Longitudinal study of changes in hip bone mineral density in Caucasian and African-American women. J Am Geriatr Soc. 2005 Feb;53(2):183-9. doi: 10.1111/j.1532-5415.2005.53101.x.

  PMID: 15673339 BACKGROUND

• Tang BM, Eslick GD, Nowson C, Smith C, Bensoussan A. Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta-analysis. Lancet. 2007 Aug 25;370(9588):657-66. doi: 10.1016/S0140-6736(07)61342-7.

  PMID: 17720017 BACKGROUND

• Vieth R, Ladak Y, Walfish PG. Age-related changes in the 25-hydroxyvitamin D versus parathyroid hormone relationship suggest a different reason why older adults require more vitamin D. J Clin Endocrinol Metab. 2003 Jan;88(1):185-91. doi: 10.1210/jc.2002-021064.

  PMID: 12519850 BACKGROUND

• Bischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson-Hughes B. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA. 2005 May 11;293(18):2257-64. doi: 10.1001/jama.293.18.2257.

  PMID: 15886381 BACKGROUND

• Latham NK, Anderson CS, Lee A, Bennett DA, Moseley A, Cameron ID; Fitness Collaborative Group. A randomized, controlled trial of quadriceps resistance exercise and vitamin D in frail older people: the Frailty Interventions Trial in Elderly Subjects (FITNESS). J Am Geriatr Soc. 2003 Mar;51(3):291-9. doi: 10.1046/j.1532-5415.2003.51101.x.

  PMID: 12588571 BACKGROUND

• MacLaughlin J, Holick MF. Aging decreases the capacity of human skin to produce vitamin D3. J Clin Invest. 1985 Oct;76(4):1536-8. doi: 10.1172/JCI112134.

  PMID: 2997282 BACKGROUND

• Dawson-Hughes B, Heaney RP, Holick MF, Lips P, Meunier PJ, Vieth R. Estimates of optimal vitamin D status. Osteoporos Int. 2005 Jul;16(7):713-6. doi: 10.1007/s00198-005-1867-7. Epub 2005 Mar 18.

  PMID: 15776217 BACKGROUND

• Vieth R, Bischoff-Ferrari H, Boucher BJ, Dawson-Hughes B, Garland CF, Heaney RP, Holick MF, Hollis BW, Lamberg-Allardt C, McGrath JJ, Norman AW, Scragg R, Whiting SJ, Willett WC, Zittermann A. The urgent need to recommend an intake of vitamin D that is effective. Am J Clin Nutr. 2007 Mar;85(3):649-50. doi: 10.1093/ajcn/85.3.649. No abstract available.

  PMID: 17344484 BACKGROUND

• Visser M, Deeg DJ, Puts MT, Seidell JC, Lips P. Low serum concentrations of 25-hydroxyvitamin D in older persons and the risk of nursing home admission. Am J Clin Nutr. 2006 Sep;84(3):616-22; quiz 671-2. doi: 10.1093/ajcn/84.3.616.

  PMID: 16960177 BACKGROUND

• Dhesi JK, Bearne LM, Moniz C, Hurley MV, Jackson SH, Swift CG, Allain TJ. Neuromuscular and psychomotor function in elderly subjects who fall and the relationship with vitamin D status. J Bone Miner Res. 2002 May;17(5):891-7. doi: 10.1359/jbmr.2002.17.5.891.

  PMID: 12009020 BACKGROUND

• Bischoff HA, Stahelin HB, Dick W, Akos R, Knecht M, Salis C, Nebiker M, Theiler R, Pfeifer M, Begerow B, Lew RA, Conzelmann M. Effects of vitamin D and calcium supplementation on falls: a randomized controlled trial. J Bone Miner Res. 2003 Feb;18(2):343-51. doi: 10.1359/jbmr.2003.18.2.343.

  PMID: 12568412 BACKGROUND

• Wicherts IS, van Schoor NM, Boeke AJ, Visser M, Deeg DJ, Smit J, Knol DL, Lips P. Vitamin D status predicts physical performance and its decline in older persons. J Clin Endocrinol Metab. 2007 Jun;92(6):2058-65. doi: 10.1210/jc.2006-1525. Epub 2007 Mar 6.

  PMID: 17341569 BACKGROUND

• Bischoff-Ferrari HA, Dawson-Hughes B, Willett WC, Staehelin HB, Bazemore MG, Zee RY, Wong JB. Effect of Vitamin D on falls: a meta-analysis. JAMA. 2004 Apr 28;291(16):1999-2006. doi: 10.1001/jama.291.16.1999.

  PMID: 15113819 BACKGROUND

• Barrett-Connor E, Siris ES, Wehren LE, Miller PD, Abbott TA, Berger ML, Santora AC, Sherwood LM. Osteoporosis and fracture risk in women of different ethnic groups. J Bone Miner Res. 2005 Feb;20(2):185-94. doi: 10.1359/JBMR.041007. Epub 2004 Oct 18.

  PMID: 15647811 RESULT

• Aloia JF, Islam S, Mikhail M. Vitamin D and Acute Respiratory Infections-The PODA Trial. Open Forum Infect Dis. 2019 Sep 4;6(9):ofz228. doi: 10.1093/ofid/ofz228. eCollection 2019 Sep.

  PMID: 31660391 DERIVED

• Aloia JF, Mikhail M, Fazzari M, Islam S, Ragolia L, Guralnik J. Physical Performance and Vitamin D in Elderly Black Women-The PODA Randomized Clinical Trial. J Clin Endocrinol Metab. 2019 May 1;104(5):1441-1448. doi: 10.1210/jc.2018-01418.

  PMID: 30496578 DERIVED

• Aloia J, Fazzari M, Islam S, Mikhail M, Shieh A, Katumuluwa S, Dhaliwal R, Stolberg A, Usera G, Ragolia L. Vitamin D Supplementation in Elderly Black Women Does Not Prevent Bone Loss: A Randomized Controlled Trial. J Bone Miner Res. 2018 Nov;33(11):1916-1922. doi: 10.1002/jbmr.3521. Epub 2018 Jul 19.

  PMID: 29905969 DERIVED

Related Links

• National Osteoporosis Foundation
• National Institute of Arthritis and Musculoskeletal and Skin Diseases

MeSH Terms

Conditions

Osteoporosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• John F. Aloia, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Academic Officer

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 3, 2018

Record last verified: 2018-06

Locations

US (1)