Different Kinds of Vitamin D Intake and Its Metabolites: Blood Levels and Bone Mineral Density. A Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- level of Vitamin D
Study Overview
Brief Summary
Patients with hypovitaminosis D are randomized into three arms of treatment:
Group A: Calcifediol 0,266mg each month Group B: Cholecalciferol 25000UI each 15 days Group C: Calcifediol 4 drops per day. Serum levels of vitamin D are dosed after one month of treatment
Detailed Description
Patients with hypovitaminosis D are randomized into three arms of treatment:
Group A: Calcifediol 0,266mg each month Group B: Cholecalciferol 25000UI each 15 days Group C: Calcifediol 4 drops per day. Serum levels of vitamin D are dosed after one month of treatment to support the best dosage of Vitamin D intake.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hypovitaminosis D (<20ng/mL)
Exclusion Criteria
- •Osteoporosis (T score <-2.5SD)
- •Renal or hepatic diseases
Arms & Interventions
Calcifediol 4 drops each day
Calcifediol 4 drops each day
Intervention: Vitamin D (Dietary Supplement)
Cholecalciferol 25.000 UI
Cholecalciferol 25000UI each 15 days
Intervention: Vitamin D (Dietary Supplement)
Calcifediol each month
Calcifediol 0,266 mg each month
Intervention: Vitamin D (Dietary Supplement)
Outcomes
Primary Outcomes
level of Vitamin D
Time Frame: Between recruitment and 6 month
Blood dosage of vitamin D
level of Vitamin D
Time Frame: Between recruitment and 1 month
Blood dosage of Vitamin D
Secondary Outcomes
- DEXA(Between recruitment and 18 months)