Vitamin D Substitution During Winter Time
- Registration Number
- NCT02958501
- Lead Sponsor
- Faculty Hospital Kralovske Vinohrady
- Brief Summary
The purpose of this study is to confirm anticipated substitution dose of the vitamin D for sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)
- Detailed Description
Vitamin D substitution is widely recommended. Suggested substitution doses are increasing over the time. No exact body requirement is known for patients with IBD at present. Aim of the study was to confirm substitution dose obtained from model.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 176
Inclusion Criteria
- Subjects with inflammatory bowel disease
Exclusion Criteria
- Liver disease
- Renal disease
- Hypercalcemia
- Hyperparathyreoidism
- Chronic pancreatitis
- Concomitant vitamin D medication
- Pregnancy
- Sarcoidosis
- Malignancy
- Inability to obtain valid data from subject
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IU/Kg/Day Colecalciferol This is dose of the drug (colecalciferol), which is based or calculated in relation to patient actual body weight IU/Day Colecalciferol This is standard dose of the drug (colecalciferol), which is not calculated in relation to patient body weight
- Primary Outcome Measures
Name Time Method Change in vitamin D blood level after follow-up interval 4 Months Change of the D vitamin level after follow-up interval in groups substituted according to weight or in fixed daily dose.
- Secondary Outcome Measures
Name Time Method Change in vitamin D after follow-up interval according to weight 4 Months Change in vitamin D after follow-up interval according to weight. Superiority of weight base dosing to fixed daily dose.
Trial Locations
- Locations (1)
Faculty Hospital Kralovske Vinohrady
🇨🇿Prague, Czech Republic