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No significant effect on bone mineral density by high doses of vitamin D3 given to overweight subjects for one year.

Jorde R, Sneve M, Torjesen PA, Figenschau Y, Hansen JB, Grimnes G - Nutr J (2010)

Bottom Line: At baseline the mean serum 25(OH)D levels were 58 nmol/L (all subjects) and increased to 141 and 100 nmol/L in the DD and DP groups, respectively.After one year, no significant differences were found between the three groups regarding change in BMD, serum OPG or RANKL.In order to disclose a positive effect, subjects with low BMD and/or low serum 25(OH)D levels need to be studied.

View Article: PubMed Central - HTML - PubMed

Affiliation: Institute of Clinical Medicine, University of Tromsø, University Hospital of North Norway, Tromsø, Norway. rolf.jorde@unn.no

ABSTRACT

Background: In meta-analyses supplementation with vitamin D appears to reduce incidence of fractures, and in cross-sectional studies there is a positive association between serum 25-hydroxyvitamin D (25(OH)D) levels and bone mineral density (BMD). However, the effect of supplementation with high doses of vitamin D on BMD is more uncertain and could in theory have both positive and negative effects.

Methods: The study was a one year, double blind placebo-controlled intervention trial performed at the University Hospital of North Norway. 421 subjects, 21 - 70 years old, were included and 312 completed the study. The subjects were randomized to vitamin D3 40.000 IU per week (DD group), vitamin D3 20.000 IU per week (DP group), or placebo (PP group). All subjects were given 500 mg calcium daily. Serum 25(OH)D, osteoprotegrin (OPG), receptoractivator of nuclear factor-kappaB ligand (RANKL), and BMD at the lumbar spine and the hip were measured before and at the end of the study.

Results: At baseline the mean serum 25(OH)D levels were 58 nmol/L (all subjects) and increased to 141 and 100 nmol/L in the DD and DP groups, respectively. After one year, no significant differences were found between the three groups regarding change in BMD, serum OPG or RANKL.

Conclusions: Supplementation with high doses of vitamin D for one year does not appear to have a negative effect on BMD in healthy subjects. In order to disclose a positive effect, subjects with low BMD and/or low serum 25(OH)D levels need to be studied.

Trial registration: The trial was registered at ClinicalTrials.gov (NCT00243256).

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Study consort diagram.
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Figure 1: Study consort diagram.

Mentions: The inclusion period started in November 2005 and the last person was included in October 2006. Of 626 subjects initially screened by telephone interview, 421 (156 men and 265 women) met the inclusion criteria and had complete datasets (Figure 1). The baseline characteristics of these subjects are shown in Table 1. Among the women, 114 were postmenopausal. The age distribution among the men and women are shown in Figure 2. The mean serum 25(OH)D levels was 57.7 ± 20.7 nmol/L and the distribution is shown in Figure 3. As expected there were a number of significant univariate correlations between the parameters measured (Table 2). However, after adjusting for confounders in the multiple linear regression model only a few of these relations remained significant. In particular, serum PTH remained as a significant and negative predictor of BMD both for L2-L4 and the hip, and female gender and high age were associated with Lg OPG (Table 3). Serum OPG was negatively correlated with BMD L2-L4 and BMD at the hip, but not after adjusting for the other covariates (data not shown). Serum RANKL was below the detection limit in 141 of the 336 subjects with RANKL measurement at baseline, and no association was found with any of the other parameters measured.


No significant effect on bone mineral density by high doses of vitamin D3 given to overweight subjects for one year.

Jorde R, Sneve M, Torjesen PA, Figenschau Y, Hansen JB, Grimnes G - Nutr J (2010)

Study consort diagram.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2818614&req=5

Figure 1: Study consort diagram.
Mentions: The inclusion period started in November 2005 and the last person was included in October 2006. Of 626 subjects initially screened by telephone interview, 421 (156 men and 265 women) met the inclusion criteria and had complete datasets (Figure 1). The baseline characteristics of these subjects are shown in Table 1. Among the women, 114 were postmenopausal. The age distribution among the men and women are shown in Figure 2. The mean serum 25(OH)D levels was 57.7 ± 20.7 nmol/L and the distribution is shown in Figure 3. As expected there were a number of significant univariate correlations between the parameters measured (Table 2). However, after adjusting for confounders in the multiple linear regression model only a few of these relations remained significant. In particular, serum PTH remained as a significant and negative predictor of BMD both for L2-L4 and the hip, and female gender and high age were associated with Lg OPG (Table 3). Serum OPG was negatively correlated with BMD L2-L4 and BMD at the hip, but not after adjusting for the other covariates (data not shown). Serum RANKL was below the detection limit in 141 of the 336 subjects with RANKL measurement at baseline, and no association was found with any of the other parameters measured.

Bottom Line: At baseline the mean serum 25(OH)D levels were 58 nmol/L (all subjects) and increased to 141 and 100 nmol/L in the DD and DP groups, respectively.After one year, no significant differences were found between the three groups regarding change in BMD, serum OPG or RANKL.In order to disclose a positive effect, subjects with low BMD and/or low serum 25(OH)D levels need to be studied.

View Article: PubMed Central - HTML - PubMed

Affiliation: Institute of Clinical Medicine, University of Tromsø, University Hospital of North Norway, Tromsø, Norway. rolf.jorde@unn.no

ABSTRACT

Background: In meta-analyses supplementation with vitamin D appears to reduce incidence of fractures, and in cross-sectional studies there is a positive association between serum 25-hydroxyvitamin D (25(OH)D) levels and bone mineral density (BMD). However, the effect of supplementation with high doses of vitamin D on BMD is more uncertain and could in theory have both positive and negative effects.

Methods: The study was a one year, double blind placebo-controlled intervention trial performed at the University Hospital of North Norway. 421 subjects, 21 - 70 years old, were included and 312 completed the study. The subjects were randomized to vitamin D3 40.000 IU per week (DD group), vitamin D3 20.000 IU per week (DP group), or placebo (PP group). All subjects were given 500 mg calcium daily. Serum 25(OH)D, osteoprotegrin (OPG), receptoractivator of nuclear factor-kappaB ligand (RANKL), and BMD at the lumbar spine and the hip were measured before and at the end of the study.

Results: At baseline the mean serum 25(OH)D levels were 58 nmol/L (all subjects) and increased to 141 and 100 nmol/L in the DD and DP groups, respectively. After one year, no significant differences were found between the three groups regarding change in BMD, serum OPG or RANKL.

Conclusions: Supplementation with high doses of vitamin D for one year does not appear to have a negative effect on BMD in healthy subjects. In order to disclose a positive effect, subjects with low BMD and/or low serum 25(OH)D levels need to be studied.

Trial registration: The trial was registered at ClinicalTrials.gov (NCT00243256).

Show MeSH
Related in: MedlinePlus