Safety and efficacy of vitamin D Nutritional, Metabolic, Endocrine
Conditions
Interventions
50µg of vitamin D3 or 100 µg of vitamin D3 or matching placebo
Duration: 12 months of treatment
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 65 years 2. Living in the community and ambulatory
Exclusion criteria
Exclusion criteria: 1. Nursing home residents 2. Regular use of vitamin D supplements with >400 IU (10 µg) vitamin D daily 3. Use of alendronate, risedronate, zoledronic acid, parathyroid hormone, or calcitonin 4. Medically diagnosed dementia 5. History of hypercalcaemia, hyperparathyroidism, lymphoma, sarcoidosis, active tuberculosis 6. History of renal calculus 7. Known to be poorly compliant with clinic visits or with taking medication 8. Recent history of alcohol or substance misuse or abuse 9. Medical history that might limit the ability of the subject to take the study treatment for the duration of the study (e.g. terminal illness) 10. Regular prescribed calcium supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary efficacy assessment will involve an ?intention-to-treat? analysis among all randomized subjects of daily dietary supplementation with vitamin D3 100 µg vs vitamin D3 50 µg 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary assessments will involve ?intention-to-treat? analyses among all randomized subjects of the effects of daily supplementation with vitamin D3 100µg vs placebo, vitamin D3 50µg vs placebo, and the difference between the two doses of vitamin D on: 1. Mean blood levels of 25(OH)D during follow-up 2. The proportions of participants with blood 25(OH)D levels >90 nmol/L at the 6 and 12 month visits 3. The proportion of participants with PTH levels suppressed into the normal range at the 6 and 12 month visits 4. The proportion of participants with calcium levels above the normal range at the 6 and 12 month visits 5. Other laboratory tests of safety: phosphate, albumin, creatinine, alkaline phosphatase 6. The changes from baseline in hsCRP, creatinine, nBNP, inflammatory cytokines (e.g. IL5, IL6, IL1ß, IFN? and TNFa) at 6 and 12 month visits, and mRNA expression markers of innate immunity at baseline and 12 month visits 7. The difference in the change from baseline in diastolic and systolic blood pressure, heart rate and arterial stiffness at 6 and 12 months 8. The difference in the changes from baseline in total cholesterol, LDL-C, HDL-C, triglycerides, apo-B and apo-A at 12 months | — |
Countries
United Kingdom
Outcome results
None listed