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The effect of normalization of sodium on bone turnover markers in patients with epilepsy. A randomized single-blinded placebo-controlled trial.

ABSTRACT: Hyponatremia [p[Na]<136 mmol/L] is an independent risk factor for decreased bone mineral density (BMD). However, whether hyponatremia represents a surrogate marker, or a direct causal relationship to bone loss remains unknown. The aim of the study was to investigate the effect of salt replacement therapy on bone turnover markers (BTM) and BMD in patients with epilepsy and chronic hyponatremia. This prospective single-blinded randomized trial investigated serum BTM and BMD, evaluated by Dual Energy X-ray Absorptiometry (DXA), in 21 patients at baseline and following three months of salt replacement therapy. Patients with two consecutive measurements of hyponatremia prior to baseline and no known osteoporosis were included from the epilepsy out-patient clinic at Rigshospitalet, Denmark. Seven patients were randomized to placebo and 14 to salt intervention. The baseline p[Na] was 134 (130.5-140) mmol/L (median (IQR)). All patients had BTM within age-specific reference ranges at baseline. Following 3 months of intervention with 3-9 g of salt daily there was no difference in levels of procollagen type 1 N-terminal propeptide (P1NP) or C-terminal cross-linking telopeptide of type 1 collagen (CTX) between placebo and intervention. Nor was there any difference in BMD evaluated at the lumbar spine (L1-L4) or at the femoral neck or total hip. In our study, salt replacement did neither affect BTM nor BMD. However, due to the small size of the study, more studies are needed to further investigate this.

SUBMITTER: Diemar SS

PROVIDER: S-EPMC7298402 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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The effect of normalization of sodium on bone turnover markers in patients with epilepsy. A randomized single-blinded placebo-controlled trial.

Diemar Sarah Seberg SS Jørgensen Niklas Rye NR Eiken Pia P Suetta Charlotte C Andersen Noémi Becser NB Sejling Anne-Sophie AS

Contemporary clinical trials communications 20200609

Hyponatremia [p[Na]<136 mmol/L] is an independent risk factor for decreased bone mineral density (BMD). However, whether hyponatremia represents a surrogate marker, or a direct causal relationship to bone loss remains unknown. The aim of the study was to investigate the effect of salt replacement therapy on bone turnover markers (BTM) and BMD in patients with epilepsy and chronic hyponatremia. This prospective single-blinded randomized trial investigated serum BTM and BMD, evaluated by Dual Ener ...[more]

PMID: 32566796

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Project description:ObjectiveVitamin D is essential for the maintenance of calcium homeostasis and bone mineralization; and low serum 25-hydroxyvitamin D (s-25-(OH)D) concentrations are associated with increased bone turnover. However, there is a lack of randomized controlled trials that have investigated the effect of vitamin D treatment on bone turnover in immigrant populations. We aimed to investigate the effect of 16-week daily vitamin D3 supplementation on bone formation marker serum procollagen type 1 amino-terminal propeptide (P1NP) and bone resorption marker C-terminal crosslinked telopeptide of type I collagen (CTX).DesignDouble-blind, randomized, placebo-controlled trial.SettingImmigrant community centers in Oslo, Norway.Participants251 healthy adults aged 18-50 years with a non-Western immigrant background were recruited.Intervention16 weeks of daily oral supplementation with either 10 μg vitamin D3, 25 μg vitamin D3, or placebo.Main outcome measuresDifference in change during the 16-week intervention between the intervention groups combined (10 or 25 μg of vitamin D3/day) and placebo, in serum P1NP and serum CTX.ResultsA total of 214 (85%) participants completed the study. S-25-(OH)D increased from 29 nmol/L at baseline to 49 nmol/L in the intervention group with no significant change in the placebo group. However, there was no difference in change of serum P1NP (mean difference: - 1.2 μg/L (95% CI: - 5.4, 2.9, P = 0.6)) and serum CTX (mean difference: - 0.005 μg/L (95% CI: - 0.03, 0.02, P = 0.7)) between those receiving vitamin D3 supplementation compared with placebo. The plasma PTH had decreased by a mean of - 1.97 pmol/L (95% CI: - 2.7, - 1.3, P < 0.0001) in the vitamin D3 group compared to placebo.ConclusionsSupplementation with 10 or 25 μg oral vitamin D3 during winter and spring for 16 weeks did not significantly affect serum P1NP and serum CTX, despite increasing s-25(OH)D and decreasing PTH in a healthy immigrant population with low baseline vitamin D status. Trial registration number: NCT01263288.

Dataset Information

The effect of normalization of sodium on bone turnover markers in patients with epilepsy. A randomized single-blinded placebo-controlled trial.

Publications

The effect of normalization of sodium on bone turnover markers in patients with epilepsy. A randomized single-blinded placebo-controlled trial.

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