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Can Vitamin D Replacement Correct Chronic Disease Anemia?
In Inflammatory Bowel Diseases Associated With Vitamin D Deficiency, Can Vitamin D Replacement Correct Chronic Disease Anemia?
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Yenimahalle
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Ankara, Yenimahalle, Turkije (Türkiye), 06060
- Gazi University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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].
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Vitamin D Supplementation
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.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in serum iron parameters
Tijdsspanne: 3 month
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Change in serum iron, ferritin and transferrin saturation in 3 months
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3 month
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Metabole ziekten
- Darmziekten
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Colon Ziekten
- Gastro-enteritis
- Stoornissen in het ijzermetabolisme
- Colitis
- Voedings- en stofwisselingsziekten
- IJzertekorten
- Colitis, ulceratief
- Ziekte van Crohn
- Inflammatoire darmziekten
- Lipiden
- Polycyclische verbindingen
- Steroïden
- Verbindingen met gefuseerde ring
- Cholestenes
- Cholestanes
- Sterolen
- Vitamine D
- Secosteroïden
- Membraanlipiden
- Cholecalciferol
Andere studie-ID-nummers
- E-66175679-514.05.02-865824
Plan Individuele Deelnemersgegevens (IPD)
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