Can Vitamin D Replacement Correct Chronic Disease Anemia?

NCT07673497 | Completed Phase 4

• 1 other identifier: E-66175679-514.05.02-865824
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-arm interventional pilot study evaluated whether vitamin D supplementation alone improves iron status in adults with inflammatory bowel disease (IBD) who are in clinical remission and have concurrent vitamin D deficiency. Because vitamin D can suppress hepcidin-a key regulator that inhibits iron absorption-the investigators hypothesized that correcting vitamin D deficiency might improve iron parameters. Adult IBD patients (Crohn's disease or ulcerative colitis) in clinical remission with serum 25-hydroxyvitamin D \<20 ng/mL, ferritin \<40 µg/L, and no anemia received oral cholecalciferol (50,000 IU weekly for 8 weeks, followed by 2,000 IU daily) and were reassessed at 3 months. The primary outcome was the within-subject change in iron parameters (serum iron, ferritin, and transferrin saturation) from baseline to 3 months. The study also examined the change in 25(OH)D and explored differences by IBD subtype and biologic therapy use.

Conditions

Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis); Vitamin D; Iron Deficiency and Overload

Keywords

Inflammatory Bowel Disease; Vitamin D; Iron

Outcome Measures

Primary Outcomes (1)

• Change in serum iron parameters

  Change in serum iron, ferritin and transferrin saturation in 3 months

  3 month

Study Arms (1)

Vitamin D Supplementation

EXPERIMENTAL

All participants received oral cholecalciferol 50,000 IU once weekly for 8 weeks (cumulative loading dose 400,000 IU), followed by oral cholecalciferol 2,000 IU daily until the 3-month follow-up visit. No iron supplementation was administered as part of the protocol.

Drug: Cholecalciferol (Vit D3)

Interventions

Cholecalciferol (Vit D3) DRUG

Oral cholecalciferol 50,000 IU once weekly for 8 weeks (loading), then 2,000 IU daily as maintenance until the 3-month follow-up visit.

Also known as: Vitamin D3

Vitamin D Supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are 18 years of age or older
• Patients who agreed to participate in the study
• Patients diagnosed with Ulcerative Colitis
• Patients diagnosed with Crohn's Disease
• Patients with vitamin D levels \<20 ng/ml\[11\]
• Crohn's patients with a Harvey Bradshaw Index below 5\[9\]
• Ulcerative colitis patients in clinical remission, defined as a partial Mayo Score ≤1 with no individual subscore \>1\[10\].

You may not qualify if:

• Patients who are under 18 years of age
• Patients with vitamin D or Iron allergy
• Crohn's patients with a Harvey Bradshaw Index of 5 or higher
• Ulcerative colitis patients with a partial Mayo Score \>1, or any individual subscore \>1
• Patients with fever

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Yenimahalle, 06060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Iron Deficiencies; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: September 30, 2022
• Primary Completion: March 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

TU (1)