Vitamin D Status in Inflammatory Bowel Disease

NCT03496246 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-04-12

No results posted yet for this study

Summary

Inflammatory bowel disease (IBD), comprising crohn's disease (CD) and ulcerative colitis (UC), is a a chronic, relapsing-remitting systemic disease. Vitamin D is a secosteroid hormone that possesses immunomodulatory properties and has been demonstrated to potentially influence inflammatory bowel disease (IBD) pathogenesis and activity.

Conditions

  • Vitamin D Deficiency
  • Inflammatory Bowel Diseases

Interventions

DIAGNOSTIC_TEST

serum total 25 hydroxycholecalciferol 25(OH) vitamin D

Quantitative measurement of serum total 25(OH) vitamin D by ELISA. Fasting (6-8 hours), venous blood samples(10ml) are collected from participants in the morning and after centrifugation, the serum are preserved in the deep freezer at -20 c. Serum levels will be determined by using commercially available kits.

DIAGNOSTIC_TEST

complete blood count (CBC)

for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils

DIAGNOSTIC_TEST

serum calcium level

measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level

DIAGNOSTIC_TEST

erythrocyte sedimentation rate (ESR)

it is an indicator of activity in inflammatory bowel disease

DIAGNOSTIC_TEST

C-reactive protein (CRP)

it is an indicator for increased possibility of infections

DIAGNOSTIC_TEST

serum creatinine

for assessment of renal function

DIAGNOSTIC_TEST

serum albumin level

for possibility of malabsorbtion in patients with inflammatory bowel disease

DIAGNOSTIC_TEST

seum alanine aminotransferase

for assessment of liver function

DIAGNOSTIC_TEST

serum potassium level

indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease

DIAGNOSTIC_TEST

serum phosphurus level

measurement of phosphurus level as it is closely related to vitamin d with its effects on its level

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2019-04-30
Completion
2019-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03496246 on ClinicalTrials.gov