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Vitamin Supplement

Low Vitamin D Group for Thalassemia

Phase 4
Waitlist Available
Led By Maria Vogiatzi, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

The purpose of this pilot study is to determine the effect of various doses of vitamin D supplementation on vitamin D stores and calcium excretion in the urine in subjects with Thalassemia Major (TM). Subjects with TM are routinely placed on vitamin D supplements because they frequently have osteoporosis (a condition in which bone tissue thins and loses density and strength) and low vitamin D stores. The amount of vitamin D supplementation that is required to raise vitamin D stores in optimal levels is not known in TM, and will be determined in this study. Finally, a recent study in TM has linked blood vitamin D levels to urine calcium excretion, which is a risk factor for kidney stones. Therefore, we want to determine changes in calcium excretion with various vitamin D doses and with increasing vitamin D stores. We plan to test 3 doses of vitamin D for 3 months in children and adults with TM. Changes in vitamin D blood levels and urinary calcium will be determined. The results of this pilot study will be used in future studies that will examine the effect of various doses of vitamin D supplementation in the treatment of osteoporosis in TM.

Eligible Conditions
  • Thalassemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Vitamin D Dose Response Curve

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Vitamin D GroupExperimental Treatment1 Intervention
Subjects in this group will receive the equivalent of 400 IU/day.
Group II: Intermediate Vitamin D groupExperimental Treatment1 Intervention
Group III: High Vitamin D GroupExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cholecalciferol
FDA approved

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,269 Total Patients Enrolled
1 Trials studying Thalassemia
6 Patients Enrolled for Thalassemia
Maria Vogiatzi, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
110 Total Patients Enrolled

Frequently Asked Questions

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~3 spots leftby Apr 2025