BEST-D is a trial assessing the efficacy and safety of vitamin D3 supplements (two doses 50µg and 100µg)
Conditions
Interventions
Trade Name: Cholecalciferol (Vitamin D3)
Product Name: Cholecalciferol
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Cholecalciferol
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible for enrolment in the study if they are: • Age = 65 years • Living in the community • Ambulatory Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: The GP will screen the practice records for all patients aged 65 years or greater who are living in the community to check for the following exclusion criteria using a screening questionnaire. In addition, the study nurse will check the exclusion criteria directly with all potential participants at their initial study visit. Exclusion criteria • Nursing home residents • Regular use of vitamin D supplements with >400 IU (10 mcg) vitamin D daily • Use of alendronate, risedronate, zoledronic acid, parathyroid hormone, or calcitonin • Medically diagnosed dementia • History of hypercalcaemia, hyperparathyroidism, lymphoma, sarcoidosis, active tuberculosis • History of renal calculus • Known to be poorly compliant with clinic visits or with taking medication • Recent history of alcohol or substance misuse or abuse • Medical history that might limit the ability to take the study treatment for the duration of the study (e.g. terminal illness) • Regular prescribed calcium supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to determine the optimal safe and effective dose of vitamin D to test in a large scale trial in older people and compare the biochemical effects on blood levels of vitamin D and parathyroid hormone of 100 mcg or 50 mcg or placebo when administered daily for one year. ;Secondary Objective: The study will also assess the effects of supplementation with vitamin D (100mcg/day or 50mcg/day or placebo) on markers of bone health, muscle strength, blood pressure and arterial stiffness, blood lipids and biomarkers of inflammation and immune function.; Primary end point(s): 1. The primary efficacy assessment will involve an “intention-to-treat” analysis among all randomized subjects of the effects of vitamin D3 100mcg daily vs vitamin D3 50mcg daily on the proportion of individuals with levels of 25(OH)D above 90 nmol/L at the end of the study. 2. A co-primary endpoint will be the difference between those allocated 100 vs 50 µg daily in the mean 25(OH)D levels at the scheduled study end. ;Timepoint(s) of evaluation of this end point: All endpoints will be evaluated at the end of 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (i) Mean blood levels of 25(OH)D during follow-up. (ii) The proportions of participants with blood 25(OH)D levels >90 nmol/L at the 6 and 12 month visits. (iii) The proportion of participants with PTH levels suppressed into the normal range at the 6 and 12 month visits. (iv) The proportion of participants with calcium levels above the normal range at the 6 and 12 month visits. (v) Other laboratory tests of safety: phosphate, albumin, creatinine, alkaline phosphatase. (vi) The changes from baseline in hsCRP, creatinine, nBNP, inflammatory cytokines (e.g. IL5, IL6, IL1ß, IFN? and TNFa) and mRNA expression, and markers of innate immunity at 6 and 12 month visits. (vii) The difference in the change from baseline in diastolic and systolic blood pressure, heart rate and arterial stiffness at 6 and 12 months. (viii) The difference in the changes from baseline in total cholesterol, LDL-C, HDL-C, triglycerides, apo-B and apo-A at 12 months. (ix) The rates of upper respiratory tract infection during follow-up. ; Timepoint(s) of evaluation of this end point: Blood analyses on the pharmacokinetics of vitamin D and related bone markers will be assessed at the end of 1 month, 6 months and 12 months of treatment. Effects on inflammation, cardiovascular function and inflammation will be assessed at 6 and 12 months of treatment. | — |
Countries
United Kingdom
Outcome results
None listed