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Vitamin DPhase 4NCT07673497

Can Vitamin D Replacement Correct Chronic Disease Anemia?

A Phase 4 study testing Cholecalciferol (Vit D3) in people with Vitamin D and Iron Deficiency and Overload, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cholecalciferol (Vit D3)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Sep 2022to 30 May 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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].

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University

    Ankara, Yenimahalle, 06060

Other trials in Turkey (Türkiye)

About this study

Official title: In Inflammatory Bowel Diseases Associated With Vitamin D Deficiency, Can Vitamin D Replacement Correct Chronic Disease Anemia?

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.

Read the detailed description

Background and Rationale Vitamin D acts as an immunomodulator and can reduce hepcidin, the principal regulator of iron metabolism that inhibits intestinal iron absorption and iron release from stores. Lower hepcidin levels may therefore increase iron availability. The investigators sought to determine whether correcting vitamin D deficiency alone could improve iron parameters. The corrective effect of vitamin D on iron parameters had previously been demonstrated in pediatric IBD patients but had not been prospectively examined in non-anemic adults. The investigators hypothesized that vitamin D replacement would significantly improve serum iron, ferritin, and transferrin saturation within 3 months, potentially through hepcidin suppression and modulation of TNF-α-dependent pathways.

Study Design and Setting This was a prospective, single-arm, single-center interventional pilot study conducted at the Inflammatory Bowel Disease outpatient clinic of the Department of Internal Medicine, Division of Gastroenterology, Gazi University Hospital, Ankara, Turkey, between September 2022 and March 2023.

Participants Eligible participants were adults (≥18 years) diagnosed with Crohn's disease or ulcerative colitis who were in clinical remission and had laboratory evidence of concurrent vitamin D deficiency [25(OH)D <20 ng/mL]. Clinical remission was defined as a Harvey-Bradshaw Index <5 for Crohn's disease and a partial Mayo Score ≤1 (with no individual subscore >1) for ulcerative colitis. Patients with vitamin D or iron allergy, anemia, active disease, or fever were excluded.

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

Outcome Measures The primary outcome was the within-subject change in iron parameters (serum iron, ferritin, and transferrin saturation) from baseline to the 3-month follow-up visit. Secondary outcomes included the within-subject change in serum 25(OH)D from baseline to follow-up, and pre-specified subgroup analyses by IBD subtype (Crohn's disease vs. ulcerative colitis) and by biologic therapy use (yes vs. no).

Statistical Analysis No a priori sample size calculation was performed; all consecutive eligible patients during the recruitment period were enrolled. Normality of continuous variables was assessed with the Kolmogorov-Smirnov and Shapiro-Wilk tests, and within-subject changes in non-normally distributed variables were analyzed using the Wilcoxon signed-rank test. Given the exploratory nature of the subgroup analyses and the small sample size, no correction for multiple comparisons was applied. A two-sided p-value <0.05 was considered statistically significant.

Enrollment Of 1,292 IBD patients screened, 43 met all eligibility criteria and were enrolled; 32 completed the 3-month follow-up.

Being tested
Cholecalciferol (Vit D3)
Keywords
Inflammatory Bowel Disease, Vitamin D, Iron
Medical subject headings
Iron Deficiencies, Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cholecalciferol (Vit D3)Drug

    Also called Vitamin D3

    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.

Study groups in NCT07673497
Study groupRoleWhat they receive
Vitamin D SupplementationExperimentalAll 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.
Receives: Drug: Cholecalciferol (Vit D3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum iron parameters

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

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2026
  2. Study start30 Sep 2022
  3. Primary completion30 Mar 2023
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07673497
Sponsor's protocol ID
E-66175679-514.05.02-865824
Status last verified
Jun 2026
First submitted
23 Jun 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: If needed and asked may be shared

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cholecalciferol (Vit D3) in people with Vitamin D and Iron Deficiency and Overload, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum iron parameters (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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