Vitamin D Deficiency
Conditions
Keywords
Quality of life
Brief summary
Vitamin D has multiple systemic effects: bone and calcium metabolism, muscle function, insulin responsiveness, body-composition regulation, cell differentiation, and the immune system. Proper status of vitamin D is found to be related to risk reduction in hypertension, cardiac and vascular diseases, autoimmune diseases, and others. Furthermore, vitamin D supplementation resulted in improved endothelial function. Limited sun exposure may lead to vitamin D deficiency, and it may be assumed that modern life styles lead to a lack of sun exposure. Long work-days may be the primary risk factor for vitamin D deficiency. The purpose of this research is to study the effect of vitamin D treatment on multi systemic functions in young healthy men with vitamin D deficiency due to working conditions.
Detailed description
The study has 2 stages: first stage would be survey of 400 employees, who will fill out a questionnaire to identify occupational and demographic risk factors, a nutritional questionnaire, and data from periodic checkups will be collected. Participants will sign a consent form for vitamin D level determinations, and for freezing blood samples. From this survey, the participants that have vitamin D deficiency (25(OH)D levels \< 20 ng/ml) will continue to the second stage of the study - administration of vitamin D or placebo. Participants in the interventional study will sign an additional consent form. Length of follow-up: one year. All parameters will be tested at 0, 6, and 12 months.
Interventions
Oral vitamin D 100,000 IU
Placebo
Sponsors
Study design
Eligibility
Inclusion criteria
* Healthy men between 20-65 years old * For stage 2: baseline 25(OH)D levels \< 20 ng/ml
Exclusion criteria
* Liver dysfunction * Kidney dysfunction * Patients with unbalanced chronic diseases * Regular use of medications that lower serum vitamin D levels, or which interfere with intestinal vitamin D absorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum level of 25(OH)D | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure, Endothelial function, Muscle strength. Quality of life, absence from work Laboratory measures:PTH, P1NP, β-CTx, Inflammation markers (hs-CRP), Fasting glucose levels, Insulin, Lipids profile | 12 months |
Countries
Israel