Göran Toss1, Per Magnusson. 1. Department of Endocrinology and Gastroenterology, County Council of Östergötland, SE-581 85 Linköping, Sweden.
Abstract
PURPOSE: The effect of 40 μg (1,600 IU) per day of vitamin D(3) on serum 25-hydroxyvitamin D (25(OH)D) and markers of bone and mineral metabolism was evaluated. METHODS: This intervention study was designed as a double-blind randomised controlled trial. Forty-five community-dwelling subjects (32 females), age 55-84 years, at 58° North latitude were supplemented for 1 year with 40 μg vitamin D(3) plus 1,000 mg calcium per day, or with 1,000 mg calcium per day for controls. Safety parameters and 25(OH)D, intact parathyroid hormone (PTH), ionized calcium, bone-specific alkaline phosphatase (BALP), and tartrate-resistant acid phosphatase isoform 5b (TRACP5b) were measured over the study period. RESULTS: All subjects supplemented with vitamin D(3) reached a 25(OH)D level above 50 nmol/L. Mean (SD) serum 25(OH)D increased from 50.4 (13.5) nmol/L to 84.2 (17.5) nmol/L, range 55.0-125.0 nmol/L in the vitamin D(3) supplemented group and the corresponding levels for the control group were 47.3 (14.1) nmol/L and 45.7 (13.4) nmol/L, range 26.0-73.0 nmol/L. No serious adverse event was recorded and the highest 25(OH)D level reached, 125.0 nmol/L, is well below toxic levels. BALP and TRACP5b did not change significantly over the study period. CONCLUSIONS: This trial suggests that a daily supplementation with 40 μg vitamin D(3) is sufficient to secure a 25(OH)D level of 50 nmol/L. No side effects were observed in the study group.
RCT Entities:
PURPOSE: The effect of 40 μg (1,600 IU) per day of vitamin D(3) on serum 25-hydroxyvitamin D (25(OH)D) and markers of bone and mineral metabolism was evaluated. METHODS: This intervention study was designed as a double-blind randomised controlled trial. Forty-five community-dwelling subjects (32 females), age 55-84 years, at 58° North latitude were supplemented for 1 year with 40 μg vitamin D(3) plus 1,000 mg calcium per day, or with 1,000 mg calcium per day for controls. Safety parameters and 25(OH)D, intact parathyroid hormone (PTH), ionizedcalcium, bone-specific alkaline phosphatase (BALP), and tartrate-resistant acid phosphatase isoform 5b (TRACP5b) were measured over the study period. RESULTS: All subjects supplemented with vitamin D(3) reached a 25(OH)D level above 50 nmol/L. Mean (SD) serum 25(OH)D increased from 50.4 (13.5) nmol/L to 84.2 (17.5) nmol/L, range 55.0-125.0 nmol/L in the vitamin D(3) supplemented group and the corresponding levels for the control group were 47.3 (14.1) nmol/L and 45.7 (13.4) nmol/L, range 26.0-73.0 nmol/L. No serious adverse event was recorded and the highest 25(OH)D level reached, 125.0 nmol/L, is well below toxic levels. BALP and TRACP5b did not change significantly over the study period. CONCLUSIONS: This trial suggests that a daily supplementation with 40 μg vitamin D(3) is sufficient to secure a 25(OH)D level of 50 nmol/L. No side effects were observed in the study group.
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