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Dose response to vitamin D supplementation in postmenopausal women: a randomized trial.
Ann Intern Med. 2012 Mar 20; 156(6):425-37.AIM

Abstract

BACKGROUND

Serum 25-hydroxyvitamin D (25-[OH]D) is considered the best biomarker of clinical vitamin D status.

OBJECTIVE

To determine the effect of increasing oral doses of vitamin D(3) on serum 25-(OH)D and serum parathyroid hormone (PTH) levels in postmenopausal white women with vitamin D insufficiency (defined as a 25-[OH]D level ≤50 nmol/L) in the presence of adequate calcium intake. These results can be used as a guide to estimate the Recommended Dietary Allowance (RDA) (defined as meeting the needs of 97.5% of the population) for vitamin D(3).

DESIGN

Randomized, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00472823)

SETTING

Creighton University Medical Center, Omaha, Nebraska.

PARTICIPANTS

163 healthy postmenopausal white women with vitamin D insufficiency enrolled in the winter or spring of 2007 to 2008 and followed for 1 year.

INTERVENTION

Participants were randomly assigned to receive placebo or vitamin D(3), 400, 800, 1600, 2400, 3200, 4000, or 4800 IU once daily. Daily calcium supplements were provided to increase the total daily calcium intake to 1200 to 1400 mg.

MEASUREMENTS

The primary outcomes were 25-(OH)D and PTH levels at 6 and 12 months.

RESULTS

The mean baseline 25-(OH)D level was 39 nmol/L. The dose response was curvilinear and tended to plateau at approximately 112 nmol/L in patients receiving more than 3200 IU/d of vitamin D(3). The RDA of vitamin D(3) to achieve a 25-(OH)D level greater than 50 nmol/L was 800 IU/d. A mixed-effects model predicted that 600 IU of vitamin D(3) daily could also meet this goal. Compared with participants with a normal body mass index (<25 kg/m(2)), obese women (≥30 kg/m(2)) had a 25-(OH)D level that was 17.8 nmol/L lower. Parathyroid hormone levels at 12 months decreased with an increasing dose of vitamin D(3) (P = 0.012). Depending on the criteria used, hypercalcemia occurred in 2.8% to 9.0% and hypercalciuria in 12.0% to 33.0% of participants; events were unrelated to dose.

LIMITATION

Findings may not be generalizable to other age groups or persons with substantial comorbid conditions.

CONCLUSION

A vitamin D(3) dosage of 800 IU/d increased serum 25-(OH)D levels to greater than 50 nmol/L in 97.5% of women; however, a model predicted the same response with a vitamin D(3) dosage of 600 IU/d. These results can be used as a guide for the RDA of vitamin D(3), but prospective trials are needed to confirm the clinical significance of these results.

PRIMARY FUNDING SOURCE

National Institute on Aging.

Authors+Show Affiliations

Bone Metabolism Unit, Creighton University School of Medicine, Omaha, Nebraska 68131, USA. jcg@creighton.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

22431675

Citation

Gallagher, J Christopher, et al. "Dose Response to Vitamin D Supplementation in Postmenopausal Women: a Randomized Trial." Annals of Internal Medicine, vol. 156, no. 6, 2012, pp. 425-37.
Gallagher JC, Sai A, Templin T, et al. Dose response to vitamin D supplementation in postmenopausal women: a randomized trial. Ann Intern Med. 2012;156(6):425-37.
Gallagher, J. C., Sai, A., Templin, T., & Smith, L. (2012). Dose response to vitamin D supplementation in postmenopausal women: a randomized trial. Annals of Internal Medicine, 156(6), 425-37. https://doi.org/10.7326/0003-4819-156-6-201203200-00005
Gallagher JC, et al. Dose Response to Vitamin D Supplementation in Postmenopausal Women: a Randomized Trial. Ann Intern Med. 2012 Mar 20;156(6):425-37. PubMed PMID: 22431675.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dose response to vitamin D supplementation in postmenopausal women: a randomized trial. AU - Gallagher,J Christopher, AU - Sai,Adarsh, AU - Templin,Thomas,2nd AU - Smith,Lynette, PY - 2012/3/21/entrez PY - 2012/3/21/pubmed PY - 2012/5/4/medline SP - 425 EP - 37 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 156 IS - 6 N2 - BACKGROUND: Serum 25-hydroxyvitamin D (25-[OH]D) is considered the best biomarker of clinical vitamin D status. OBJECTIVE: To determine the effect of increasing oral doses of vitamin D(3) on serum 25-(OH)D and serum parathyroid hormone (PTH) levels in postmenopausal white women with vitamin D insufficiency (defined as a 25-[OH]D level ≤50 nmol/L) in the presence of adequate calcium intake. These results can be used as a guide to estimate the Recommended Dietary Allowance (RDA) (defined as meeting the needs of 97.5% of the population) for vitamin D(3). DESIGN: Randomized, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00472823) SETTING: Creighton University Medical Center, Omaha, Nebraska. PARTICIPANTS: 163 healthy postmenopausal white women with vitamin D insufficiency enrolled in the winter or spring of 2007 to 2008 and followed for 1 year. INTERVENTION: Participants were randomly assigned to receive placebo or vitamin D(3), 400, 800, 1600, 2400, 3200, 4000, or 4800 IU once daily. Daily calcium supplements were provided to increase the total daily calcium intake to 1200 to 1400 mg. MEASUREMENTS: The primary outcomes were 25-(OH)D and PTH levels at 6 and 12 months. RESULTS: The mean baseline 25-(OH)D level was 39 nmol/L. The dose response was curvilinear and tended to plateau at approximately 112 nmol/L in patients receiving more than 3200 IU/d of vitamin D(3). The RDA of vitamin D(3) to achieve a 25-(OH)D level greater than 50 nmol/L was 800 IU/d. A mixed-effects model predicted that 600 IU of vitamin D(3) daily could also meet this goal. Compared with participants with a normal body mass index (<25 kg/m(2)), obese women (≥30 kg/m(2)) had a 25-(OH)D level that was 17.8 nmol/L lower. Parathyroid hormone levels at 12 months decreased with an increasing dose of vitamin D(3) (P = 0.012). Depending on the criteria used, hypercalcemia occurred in 2.8% to 9.0% and hypercalciuria in 12.0% to 33.0% of participants; events were unrelated to dose. LIMITATION: Findings may not be generalizable to other age groups or persons with substantial comorbid conditions. CONCLUSION: A vitamin D(3) dosage of 800 IU/d increased serum 25-(OH)D levels to greater than 50 nmol/L in 97.5% of women; however, a model predicted the same response with a vitamin D(3) dosage of 600 IU/d. These results can be used as a guide for the RDA of vitamin D(3), but prospective trials are needed to confirm the clinical significance of these results. PRIMARY FUNDING SOURCE: National Institute on Aging. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/22431675/Dose_response_to_vitamin_D_supplementation_in_postmenopausal_women:_a_randomized_trial_ L2 - https://www.annals.org/aim/fullarticle/doi/10.7326/0003-4819-156-6-201203200-00005 DB - PRIME DP - Unbound Medicine ER -