Impact of Calcium and Two Doses of Vitamin D on Bone Metabolism in the Elderly: A Randomized Controlled Trial

Abstract

The optimal dose of vitamin D to optimize bone metabolism in the elderly is unclear. We tested the hypothesis a vitamin D, at a dose higher than recommended by the Institute of Medicine (IOM), has a beneficial effect on bone remodeling and mass. In this double blind trial we randomized 257 overweight elderly subjects to receive 1000 mg of elemental calcium citrate/day, and the daily equivalent of 3,750IU/day or 600 IU/day of vitamin D3 for one year. The subjects’ mean age was 71±4 years, body mass index 30±4 kg/m2, 55% were women, and 222 completed the 12-months follow-up. Mean serum 25 hydroxy-vitamin D (25OHD) was 20 ng/ml, and rose to 26 ng/ml in the low dose, and 36ng/ml in the high dose arm, at one year (p<0.05). Plasma parathyroid hormone, osteocalcin, and C-terminal telopeptide (Cross Laps) levels decreased significantly by 20–22% in both arms, but there were no differences between the two groups for any variable, at 6 or 12 months, with the exception of serum calcitriol that was higher in the high-dose group at 12 months. Bone mineral density (BMD) increased significantly at total hip and lumbar spine, but not femoral neck, in both arms, while subtotal body BMD increased in the high-dose group only, at one year. However, there were no significant differences in percent change BMD between the 2 arms at any skeletal site. Subjects with serum 25OHD below 20 ng/ml and PTH level above 76 pg/ml, showed a trend for higher BMD increments at all skeletal sites, in the high-dose group, that reached significance at the hip. Adverse events were comparable in the two study arms. This controlled trial demonstrates little additional benefit in vitamin D supplementation at a dose exceeding the IOM recommendation of 600IU/day on BMD and bone markers, in overweight elderly individuals.

Vitamin D in the Middle East and North Africa

“…The search yielded 1280 citations after removal of duplicates. We screened the full text of 242 papers, and identified 14 relevant trials ( Shahgheibi et al, 2016 ; Vaziri et al, 2016 ; Saad et al, 2018 ; Talaat et al, 2016 ; Taheri et al, 2015 ; Tepper et al, 2016 ; Zarrin et al, 2017 ; Kamelian et al, 2017 ; Jozanikohan and Kazemi Saleh, 2015 ; Mohammad-Alizadeh-Charandabi et al, 2015 ; Shehata, 2016 ; Rahme et al, 2017 ; Mojibian et al, 2015 ; Behjat Sasan et al, 2017 ).…”

“…The current update identified 8 trials: 5 from Iran ( Taheri et al, 2015 ; Zarrin et al, 2017 ; Kamelian et al, 2017 ; Jozanikohan and Kazemi Saleh, 2015 ; Mohammad-Alizadeh-Charandabi et al, 2015 ), 1 from Egypt ( Shehata, 2016 ), one from occupied Palestine/Israel ( Tepper et al, 2016 ), and one from Lebanon ( El-Hajj Fuleihan et al, 2016 ; Rahme et al, 2017 ). The latter was included in our previous review ( Chakhtoura et al, 2017a ), since we had access to primary data, but it was not published then, and is described herein ( Table 1 ) ( El-Hajj Fuleihan et al, 2016 ; Taheri et al, 2015 ; Tepper et al, 2016 ; Zarrin et al, 2017 ; Kamelian et al, 2017 ).…”

“…Vitamin D at a dose of 50,000 IU/week for 9 months in 119 Iranian women and men resulted in a significant increase in FGF23 level, compared to placebo ( Kamelian et al, 2017 ). An adequately powered study of 221 elderly overweight Lebanese individuals, with a baseline femoral T-score of −1.7 (0.8), demonstrated that vitamin D3 at daily equivalent doses of 600 IU or 3570 IU yielded similar increments in BMD at one year, despite a significant difference in the achieved 25(OH)D level, 36 (9.7) ng/ml in the high dose arm and 26 (7) ng/ml in the low dose arm ( Rahme et al, 2017 ).…”

Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study

“…This heterogeneity can be explained, at least in part, by the scarcity of comparative pharmacokinetics (PK) data for the different dosing schedules [11][12][13]. Furthermore, there is growing evidence suggesting that the treatment schedule itself (i.e., bolus vs. frequent administration) may impact differently on the effectiveness of the treatment [14,15] and also on clinical outcome, with recent studies and few meta-analyses showing more promising results with frequent administration schedules on skeletal and extra-skeletal outcomes [9,10,[16][17][18].…”

Compliance Of Calcium+Vitamin D Treatment Among Elderly

“…[1,2] The primary goal is to reduce or stop bone loss and the associated fracture risk. [1][2][3][4] The mortality and morbidity rates associated with fracture increase with age. Ca+vitD supplementation has been shown to reduce the rate of all types of fracture in individuals over 50 years of age, and it was reported in a meta-analysis that included 64,000 individuals that the treatment led to a 2-fold decrease in the incidence of fracture.…”