Treatment of Vitamin D Insufficiency in Postmenopausal Women: A Randomized Clinical Trial | Geriatrics | JAMA Internal Medicine | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 18.204.227.34. Please contact the publisher to request reinstatement.
Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    1 Comment for this article
    EXPAND ALL
    Primary Results Not Included in Manuscript
    Michael P. Carson MD, Nishita Parikh MD | Jersey Shore University Medical Center
    Dr. Parikh and I decided to review this article for our residency's journal club using the Critical Appraisal tool from the Oxford Center for Evidence Based Medicine (www.cebm.net). We were frustrated that the results for the primary endpoint of Fractional Calcium Absorption were not included in the primary document, to which we have access via our hospital library, but in \"Supplement 2\" that must be obtained via an interlibrary loan. We are confused why the authors, editors and/or reviewers would make it difficult for a clinician to critically review this article in an efficient manner. However, it was an interesting lesson for our residents as the first question I ask in our journal club is \"Was it easy to read and interpret?\".
    CONFLICT OF INTEREST: None Reported
    READ MORE
    Original Investigation
    October 2015

    Treatment of Vitamin D Insufficiency in Postmenopausal Women: A Randomized Clinical Trial

    Author Affiliations
    • 1Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison
    • 2Quality and Patient Safety Analysis, Saint Luke’s Health System, Kansas City, Missouri
    • 3Department of Computing and Biometry, University of Wisconsin College of Agriculture and Life Sciences, Madison
    JAMA Intern Med. 2015;175(10):1612-1621. doi:10.1001/jamainternmed.2015.3874
    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

    ×