Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

Tomas Bata Hospital, Czech Republic

Status and phase: Enrolling; Phase 4

Conditions: Vitamin D Substitution

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT05733117

K092022

Details and patient eligibility

About

The purpose of this study is to compare efficacy of the suplementation using the conventional oral and oral nano form of the calciferol.

Full description

Conventional oral vit D formulas have variable availability esp. in IBD patients. Oral nano vitamin D is absorbed in the mouth. The aim of this study is to compare the efficacy of both formulations by matching vitD levels after supplementation and to determine the equivalent dose.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The inflammatory bowel disease patients

Exclusion criteria

• Liver and renal disease
• Hypercalcemia
• Hyperparathyreoidism
• Chronic pancreatitis
• Concomitant vitamin D medication
• Pregnancy
• Sarcoidosis
• Malignancy
• Inability to obtain valid data from subject

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

NanoVitD

Active Comparator group

Description:

Oral nano form of the calciferol

Treatment:

Drug: Vitamin D

ConvVitD

Active Comparator group

Description:

Conventional oral calciferol

Treatment:

Drug: Vitamin D