Vitamin D Substitution During Winter Time

Faculty Hospital Kralovske Vinohrady

Status and phase: Unknown; Phase 4

Conditions: Vitamin D Substitution

Treatments: Drug: Colecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT02958501

DV1607

Details and patient eligibility

About

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)

Full 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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

IU/Day

Active Comparator group

Description:

This is standard dose of the drug (colecalciferol), which is not calculated in relation to patient body weight

Treatment:

Drug: Colecalciferol

IU/Kg/Day

Active Comparator group

Description:

This is dose of the drug (colecalciferol), which is based or calculated in relation to patient actual body weight

Treatment:

Drug: Colecalciferol