Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2012
The effect of high-dose vitamin D on bone mineral density and bone turnover markers in postmenopausal women with low bone mass--a randomized controlled 1-year trial.
Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01991054 (A Prospective, Double Blind, Randomized, Phase 4, Clinical Trial of The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Double Blind, Randomized, Phase 4, Clinical Trial of The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 78 citations in OpenAlex.
- Effects of vitamin D supplementation on markers for cardiovascular disease and type 2 diabetes: an individual participant data meta-analysis of randomized controlled trials.The American journal of clinical nutrition · 2018Pooled it
- Concurrent effects of high-intensity interval training and vitamin D supplementation on bone metabolism among women diagnosed with osteoporosis: a randomized controlled trial.BMC musculoskeletal disorders · 2025Trial
- Trial
- Trial
- Calcifediol (25-hydroxyvitamin D) improvement and calcium-phosphate metabolism of alendronate sodium/vitamin DBMC musculoskeletal disorders · 2018Trial
- Effect of isolated vitamin D supplementation on bone turnover markers in younger postmenopausal women: a randomized, double-blind, placebo-controlled trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2018Trial
- The effect of high-dose vitamin DOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2018Trial
- Impact of Calcium and Two Doses of Vitamin D on Bone Metabolism in the Elderly: A Randomized Controlled Trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2017Trial
- Three doses of vitamin D, bone mineral density, and geometry in older women during modest weight control in a 1-year randomized controlled trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2017Trial
- Phillygenin Improves the Focal Adhesion Kinase/Glycogen Synthase Kinase 3β/β-Catenin Axis to Promote Mesenchymal Stem Cell Osteogenic Differentiation.Phytotherapy research : PTR · 2025Article
- Bone turnover markers, and growth and bone parameters in infants participating in a vitamin D intervention study.Endocrine connections · 2025Article
- Does higher serum 25-hydroxyvitamin D levels will harm bone mineral density?: a cross-sectional study.BMC endocrine disorders · 2024Article
- Article
- Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate.EFSA journal. European Food Safety Authority · 2023Article
- Vitamin D status and its associations with bone mineral density, bone turnover markers, and parathyroid hormone in Chinese postmenopausal women with osteopenia and osteoporosis.Frontiers in nutrition · 2023Article
- Bone turnover markers as surrogates of fracture healing after intramedullary fixation of tibia and femur fractures.Bone & joint research · 2022Article
- Safety of Vitamin D Food Fortification and Supplementation: Evidence from Randomized Controlled Trials and Observational Studies.Foods (Basel, Switzerland) · 2021Article
- Serum PTH is not a good marker for defining a threshold for vitamin D deficiency.Endocrine connections · 2020Article
- Genetic Components of 25-Hydroxyvitamin D Increase in Three Randomized Controlled Trials.Journal of clinical medicine · 2020Article
- Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledVitamin D is widely used in osteoporosis treatment, although the optimal dose is not known. This 1-year clinical study among 297 women aged 50-80 years old showed that a vitamin D(3) dose of 6,500 IU/day was not better than the standard dose of 800 IU/day in improving bone mineral density (BMD) in the hip and spine.
introductionThe purpose of this study was to determine whether a high dose of vitamin D(3) was better than the standard dose in improving BMD and reducing bone turnover in postmenopausal women with reduced bone mass.
methodsThe study was a 1-year randomized double-blind controlled trial comparing high-dose vitamin D(3) with the standard dose. Postmenopausal women (n = 297) with a BMD T-score ≤ -2.0 in either lumbar spine (L2-4) or total hip were included and randomized to 6,500 IU vitamin D(3)/day (20,000 IU twice per week + 800 IU/day) or 800 IU vitamin D(3)/day (placebo twice per week + 800 IU/day). Both groups were given 1,000 mg elemental calcium/day. The primary endpoint was a change in BMD in total hip and lumbar spine (L2-4).
resultsAfter 1 year, serum 25-hydroxyvitamin D (25(OH)D) increased [mean (SD)] from 71 (23) to 185 (34) nmol/l and from 71 (22) to 89 (17) nmol/l in the high- and standard-dose vitamin D groups, respectively. BMD at all measurement sites was unchanged or slightly improved with no significant differences between the groups. Although bone turnover was reduced in both groups, the more pronounced reduction in serum levels of the bone formation marker P1NP in the standard-dose group may indicate that this treatment was more efficient. Adverse events did not differ between the groups.
conclusionsOne year treatment with 6,500 IU vitamin D(3)/day was not better than 800 IU/day regarding BMD in vitamin D-replete postmenopausal women with reduced bone mass and was less efficient in reducing bone turnover.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.