“What is an appropriate dosage and interval of vitamin D2 supplementation to achieve a sufficiency level in postmenopausal women of Thailand?” A randomized, double-blind, placebo-controlled trial

AbstractObjectiveThis study primarily evaluated serum 25-hydroxy vitamin D levels in postmenopausal women with vitamin D insufficiency who received different dosages and intervals of vitamin D2 supplementation. We secondarily evaluated the percentages of those who achieved vitamin D sufficiency level (Defined as ≥30 ng/ml).Study designRandomized double-blind, placebo-controlled trial.MethodsPostmenopausal women who met the criteria of vitamin D insufficiency (<30 ng/mL) were randomized into 4 groups (N = 25/group). Participants received a 12 week-treatment of different dosages and intervals of vitamin D2 (placebo, vitamin D2 20,000 IU/2 weeks, vitamin D2 20,000 IU/week, and vitamin D2 40,000 IU/week). Serum total 25-hydroxy vitamin D was determined at baseline, after 4 and 12 weeks of supplementation with electrochemiluminescence immunoassay (Elecys, Roche Diagnostics). Changes of 25-hydroxy vitamin D levels were compared among the groups.ResultsForty seven percent of postmenopausal women (100/212) screened for study enrolment were found to have vitamin D insufficiency. At 12 weeks, serum 25-hydroxy vitamin D increased significantly from baseline in all groups (p < 0.01) (mean serum 25-hydroxy vitamin D level increased from 23.03 ± 4.56 at baseline to 25.60 ± 4.79 ng/ml (placebo), 23.54 ± 5.14 to 27.83 ± 5.27 ng/ml (vitamin D2 20,000 IU/2 weeks), 22.68 ± 5.21 to 30.50 ± 5.14 ng/ml (vitamin D2 20,000 IU/week), and 22.88 ± 4.83 to 37.89 ± 5.47 ng/ml (vitamin D2 40,000 IU/week)). In addition, the 25-hydroxy vitamin D levels were statistically significantly different at 4 and 12 weeks (p < 0.01) among all 4 groups. The percentages of those achieving vitamin D sufficiency level after 12 weeks of supplementation were 16% (placebo), 27.3% (vitamin D2 20,000 IU/2 weeks), 44% (vitamin D2 20,000 IU/week), and 86.4% (vitamin D2 40,000 IU/week); statistically significantly different among the four groups (p < 0.01). There was no participant with 25-hydroxy vitamin D after 12 weeks of >50 ng/mL in this study.ConclusionVitamin D2 40,000 IU/week was found to be the most effective dosage for postmenopausal women in this study to achieve serum vitamin D sufficiency level

Effects of Oral Multi-Vitamin Multi-Mineral Supplement Formulations on Laboratory Outcomes and Quality of Life: A Quasi-Experimental Study.

BackgroundMulti-vitamin multi-mineral (MVMM) products often come in several single-substance capsules from different manufacturers. However, attempts to mix several vitamins and minerals into one MVMM product have been complicated and often involve legal concerns. This study aimed to comparatively investigate the changes in laboratory parameters and the quality of life (QOL) among individuals who received different MVMM formulations.MethodsThis three-arm non-randomized controlled trial was conducted at VitalLife Scientific Wellness Center (VSWC), Bangkok, Thailand. A total of 72 healthy adult individuals with total serum 25-(OH)D level of 20-29 ng/ml were invited to choose from the three available options, namely, (1) Hydro-Cell-Key (HCK®, Hepart AG, Switzerland) contains vitamin D3 2,000 IU, vitamin C 1,000 mg, vitamin E 166 mg, vitamin A 1 mg, coenzyme Q10 30 mg, natural carotenoids 8 mg, and citrus flavonoids 200 mg in granule formulation; (2) VTL-7 (VWSC) contains similar vitamins and minerals but in capsule formulation; and (3) placebo capsule (no supplement). The 36-Item Short-Form Health Survey (SF-36) was used to measure QOL at baseline, month 3 and 6. A generalized estimating equation (GEE) was used to compare the repeated-measure outcomes across the three groups. This study was registered at the Thai Clinical Trial Registration (TCTR20190205002) and approved by the Bumrungrad International Institutional Review Board (BI-IRB No.258-10-18PhFub).ResultsBoth VTL-7 and HCK saw a significantly higher increase in vitamin D than placebo at months 3 and 6, i.e., VTL-7 from 25.15 ± 2.13 to 35.53 ± 6.11 (p p p = 0.005) and 27.40 ± 5.24 (p = 0.012); and placebo from 24.00 ± 2.73 to 23.05 ± 4.39 (p = 0.273) and 22.30 ± 6.23 (p = 0.200), respectively. Similarly, β-carotenoids of VTL-7 vs. HCK groups significantly increased from 0.88 ± 0.68 vs. 0.94 ± 0.55 at baseline to 3.03 ± 1.79 (p p = 0.125) and 3.26 ± 1.74 (p p = 0.064), respectively. These findings were corroborated through the GEE analysis. Other micronutrients at months 3 and 6 did not increase significantly from baseline in any group. The overall QOL among the three groups in terms of physical (p = 0.560) and mental (p = 0.750) health increased but was not statistically significant.ConclusionThe supplements of MVMM in capsule formulation increased the serum levels of some micronutrients to a higher extent than that of granule formulation. Participant adherence remains a potential confounder and should be further explored.Clinical trial registrationidentifier: TCTR20190205002

Effect of once-yearly zoledronic acid on the spine and hip as measured by quantitative computed tomography: results of the HORIZON Pivotal Fracture Trial.

Changes in bone mineral density and bone strength following treatment with zoledronic acid (ZOL) were measured by quantitative computed analysis (QCT) or dual-energy X-ray absorptiometry (DXA). ZOL treatment increased spine and hip BMD vs placebo, assessed by QCT and DXA. Changes in trabecular bone resulted in increased bone strength. INTRODUCTION: To investigate bone mineral density (BMD) changes in trabecular and cortical bone, estimated by quantitative computed analysis (QCT) or dual-energy X-ray absorptiometry (DXA), and whether zoledronic acid 5 mg (ZOL) affects bone strength. METHODS: In 233 women from a randomized, controlled trial of once-yearly ZOL, lumbar spine, total hip, femoral neck, and trochanter were assessed by DXA and QCT (baseline, Month 36). Mean percentage changes from baseline and between-treatment differences (ZOL vs placebo, t-test) were evaluated. RESULTS: Mean between-treatment differences for lumbar spine BMD were significant by DXA (7.0%, p &lt; 0.01) and QCT (5.7%, p &lt; 0.0001). Between-treatment differences were significant for trabecular spine (p = 0.0017) [non-parametric test], trabecular trochanter (10.7%, p &lt; 0.0001), total hip (10.8%, p &lt; 0.0001), and compressive strength indices at femoral neck (8.6%, p = 0.0001), and trochanter (14.1%, p &lt; 0.0001). CONCLUSIONS: Once-yearly ZOL increased hip and spine BMD vs placebo, assessed by QCT vs DXA. Changes in trabecular bone resulted in increased indices of compressive strength