Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2024-01-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Vitamin D Substitution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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NanoVitD

Oral nano form of the calciferol

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

cholecalciferol

ConvVitD

Conventional oral calciferol

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

cholecalciferol

Interventions

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Vitamin D

cholecalciferol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No