Trial reportCalcified tissue international2026
Low Prevalence of Exploratory Biochemical Patterns Compatible with Osteomalacia in a Large Cohort of Participants with Low Serum 25-Hydroxyvitamin D Levels.
Trial report in Calcified tissue international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02750293 (The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors in Subjects With Low Serum 25-hydroxyvitamin D Levels), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors in Subjects With Low Serum 25-hydroxyvitamin D Levels
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The threshold for vitamin D deficiency is mainly based on osteomalacia prevention. Osteomalacia is diagnosed by bone biopsy, but may potentially also be identified biochemically. Our objective was to examine the prevalence of exploratory biochemical patterns compatible with osteomalacia in a population with low vitamin D status, as well as the effect of vitamin D supplementation on the biochemical parameters. The study was cross-sectional followed by a randomized controlled trial (trial registration number: NCT02750293). The participants were recruited from the population-based Tromsø study. Plasma parathyroid hormone, serum calcium, alkaline phosphatase and bone-specific alkaline phosphatase were measured. 423 participants were included in the cross-sectional part and 382 completed the randomized controlled trial (194 given vitamin D (100,000 IU as a loading dose followed by 20,000 IU per week for four months) and 188 given placebo). The mean serum 25-hydroxyvitamin D level in the cohort was 34 nmol/L. None of the participants had a combination of high (above reference range) serum parathyroid hormone, high alkaline phosphatase, and low (below reference range) serum calcium. With the most permissive exploratory biochemical pattern the prevalence was 8.3%. In the intervention study vitamin D significantly reduced plasma parathyroid hormone and alkaline phosphatase and increased serum calcium as compared to placebo. In conclusion, the prevalence of the explored biochemical patterns compatible with ostemalacia was low and strongly dependent on the analytical thresholds applied. In the absence of validation against bone histomorphometry, these findings cannot determine the prevalence of osteomalacia or establish an appropriate serum 25OHD threshold.
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