Tags

Type your tag names separated by a space and hit enter

Treatment of Vitamin D Insufficiency in Postmenopausal Women: A Randomized Clinical Trial.
JAMA Intern Med 2015; 175(10):1612-21JIM

Abstract

IMPORTANCE

Experts debate optimal 25-hydroxyvitamin D (25[OH]D) levels for musculoskeletal health.

OBJECTIVE

To compare the effects of placebo, low-dose cholecalciferol, and high-dose cholecalciferol on 1-year changes in total fractional calcium absorption, bone mineral density, Timed Up and Go and five sit-to-stand tests, and muscle mass in postmenopausal women with vitamin D insufficiency.

DESIGN, SETTING, AND PARTICIPANTS

This randomized, double-blind, placebo-controlled clinical trial was conducted at a single center in Madison, Wisconsin, from May 1, 2010, through July 31, 2013, and the final visit was completed on August 8, 2014. A total of 230 postmenopausal women 75 years or younger with baseline 25(OH)D levels of 14 through 27 ng/mL and no osteoporosis were studied.

INTERVENTIONS

Three arms included daily white and twice monthly yellow placebo (n=76), daily 800 IU vitamin D3 and twice monthly yellow placebo (n=75), and daily white placebo and twice monthly 50,000 IU vitamin D3 (n=79). The high-dose vitamin D regimen achieved and maintained 25(OH)D levels≥30 ng/mL.

MAIN OUTCOMES AND MEASURES

Outcome measures were 1-year change in total fractional calcium absorption using 2 stable isotopes, bone mineral density and muscle mass using dual energy x-ray absorptiometry, Timed Up and Go and five sit-to-stand tests, functional status (Health Assessment Questionnaire), and physical activity (Physical Activity Scale for the Elderly), with Benjamini-Hochberg correction of P values to control for the false discovery rate.

RESULTS

After baseline absorption was controlled for, calcium absorption increased 1% (10 mg/d) in the high-dose arm but decreased 2% in the low-dose arm (P = .005 vs high-dose arm) and 1.3% in the placebo arm (P = .03 vs high-dose arm). We found no between-arm changes in spine, mean total-hip, mean femoral neck, or total-body bone mineral density, trabecular bone score, muscle mass, and Timed Up and Go or five sit-to-stand test scores. Likewise, we found no between-arm differences for numbers of falls, number of fallers, physical activity, or functional status.

CONCLUSIONS AND RELEVANCE

High-dose cholecalciferol therapy increased calcium absorption, but the effect was small and did not translate into beneficial effects on bone mineral density, muscle function, muscle mass, or falls. We found no data to support experts' recommendations to maintain serum 25(OH)D levels of 30 ng/mL or higher in postmenopausal women. Instead, we found that low- and high-dose cholecalciferol were equivalent to placebo in their effects on bone and muscle outcomes in this cohort of postmenopausal women with 25(OH)D levels less than 30 ng/mL.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00933244.

Authors+Show Affiliations

Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison.Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison2Quality and Patient Safety Analysis, Saint Luke's Health System, Kansas City, Missouri.Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison.Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison.Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison.Department of Computing and Biometry, University of Wisconsin College of Agriculture and Life Sciences, Madison.Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

26237520

Citation

Hansen, Karen E., et al. "Treatment of Vitamin D Insufficiency in Postmenopausal Women: a Randomized Clinical Trial." JAMA Internal Medicine, vol. 175, no. 10, 2015, pp. 1612-21.
Hansen KE, Johnson RE, Chambers KR, et al. Treatment of Vitamin D Insufficiency in Postmenopausal Women: A Randomized Clinical Trial. JAMA Intern Med. 2015;175(10):1612-21.
Hansen, K. E., Johnson, R. E., Chambers, K. R., Johnson, M. G., Lemon, C. C., Vo, T. N., & Marvdashti, S. (2015). Treatment of Vitamin D Insufficiency in Postmenopausal Women: A Randomized Clinical Trial. JAMA Internal Medicine, 175(10), pp. 1612-21. doi:10.1001/jamainternmed.2015.3874.
Hansen KE, et al. Treatment of Vitamin D Insufficiency in Postmenopausal Women: a Randomized Clinical Trial. JAMA Intern Med. 2015;175(10):1612-21. PubMed PMID: 26237520.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment of Vitamin D Insufficiency in Postmenopausal Women: A Randomized Clinical Trial. AU - Hansen,Karen E, AU - Johnson,R Erin, AU - Chambers,Kaitlin R, AU - Johnson,Michael G, AU - Lemon,Christina C, AU - Vo,Tien Nguyen Thuy, AU - Marvdashti,Sheeva, PY - 2015/8/4/entrez PY - 2015/8/4/pubmed PY - 2016/1/9/medline SP - 1612 EP - 21 JF - JAMA internal medicine JO - JAMA Intern Med VL - 175 IS - 10 N2 - IMPORTANCE: Experts debate optimal 25-hydroxyvitamin D (25[OH]D) levels for musculoskeletal health. OBJECTIVE: To compare the effects of placebo, low-dose cholecalciferol, and high-dose cholecalciferol on 1-year changes in total fractional calcium absorption, bone mineral density, Timed Up and Go and five sit-to-stand tests, and muscle mass in postmenopausal women with vitamin D insufficiency. DESIGN, SETTING, AND PARTICIPANTS: This randomized, double-blind, placebo-controlled clinical trial was conducted at a single center in Madison, Wisconsin, from May 1, 2010, through July 31, 2013, and the final visit was completed on August 8, 2014. A total of 230 postmenopausal women 75 years or younger with baseline 25(OH)D levels of 14 through 27 ng/mL and no osteoporosis were studied. INTERVENTIONS: Three arms included daily white and twice monthly yellow placebo (n=76), daily 800 IU vitamin D3 and twice monthly yellow placebo (n=75), and daily white placebo and twice monthly 50,000 IU vitamin D3 (n=79). The high-dose vitamin D regimen achieved and maintained 25(OH)D levels≥30 ng/mL. MAIN OUTCOMES AND MEASURES: Outcome measures were 1-year change in total fractional calcium absorption using 2 stable isotopes, bone mineral density and muscle mass using dual energy x-ray absorptiometry, Timed Up and Go and five sit-to-stand tests, functional status (Health Assessment Questionnaire), and physical activity (Physical Activity Scale for the Elderly), with Benjamini-Hochberg correction of P values to control for the false discovery rate. RESULTS: After baseline absorption was controlled for, calcium absorption increased 1% (10 mg/d) in the high-dose arm but decreased 2% in the low-dose arm (P = .005 vs high-dose arm) and 1.3% in the placebo arm (P = .03 vs high-dose arm). We found no between-arm changes in spine, mean total-hip, mean femoral neck, or total-body bone mineral density, trabecular bone score, muscle mass, and Timed Up and Go or five sit-to-stand test scores. Likewise, we found no between-arm differences for numbers of falls, number of fallers, physical activity, or functional status. CONCLUSIONS AND RELEVANCE: High-dose cholecalciferol therapy increased calcium absorption, but the effect was small and did not translate into beneficial effects on bone mineral density, muscle function, muscle mass, or falls. We found no data to support experts' recommendations to maintain serum 25(OH)D levels of 30 ng/mL or higher in postmenopausal women. Instead, we found that low- and high-dose cholecalciferol were equivalent to placebo in their effects on bone and muscle outcomes in this cohort of postmenopausal women with 25(OH)D levels less than 30 ng/mL. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00933244. SN - 2168-6114 UR - https://www.unboundmedicine.com/medline/citation/26237520/Treatment_of_Vitamin_D_Insufficiency_in_Postmenopausal_Women:_A_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/jamainternmed.2015.3874 DB - PRIME DP - Unbound Medicine ER -