Dose response to vitamin D supplementation in postmenopausal women: a randomized trial
Gallagher JC, Sai A, Templin T, Smith L
Annals of internal medicine · 240 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute on Aging
- Gobierno
- NIA NIH HHS
- Subvenciones
- National Institute on Aging (R01 AG28168)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2012-03-20 · Ann Intern Med · vol. 156 · número 6 · págs. 425–437
- Editorial
- American College of Physicians
- Citado
- 310 citas · más que el 100% de estudios similares · 26.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 49 trabajos
- Acceso
- De pago
- Áreas de investigación
- Vitamin D Research Studies · Bone health and osteoporosis research · Parathyroid Disorders and Treatments
- Palabras clave
- vitamin D3 supplementation, dose-response relationship, 25-hydroxyvitamin D, vitamin D insufficiency, postmenopausal women, parathyroid hormone, RDA, obesity, body mass index, calcium intake, vitamin D status biomarkers, vitamin D deficiency prevention
- MeSH
- humans, hypercalcemia, vitamin d deficiency, obesity, calcium, dietary, parathyroid hormone, vitamin d, body mass index, prospective studies, postmenopause, dose-response relationship, drug, dietary supplements, aged, aged, 80 and over, middle aged, female, hypercalciuria, biomarkers
4 autores
- John Christopher Gallagher🇺🇸Creighton University; University of Nebraska Medical Center
- Adarsh J. Sai🇺🇸Creighton University; Loma Linda University; Loma Linda University Health Care; University of Nebraska Medical Center
- Thomas Templin🇺🇸Creighton University; University of Nebraska Medical Center
- Lynette M. Smith🇺🇸Creighton University; University of Nebraska Medical Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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