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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests different doses of vitamin D3 in children and adults with Thalassemia Major to see how it affects their blood vitamin D levels and urine calcium levels. People with this condition often have low vitamin D and weak bones. The study aims to find the best dose to improve their health without causing too much calcium in their urine. Vitamin D3 has been studied for its effects on bone health and vitamin D levels in patients with thalassemia major, who often suffer from vitamin D deficiency and related complications.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Vitamin D Dose Response Curve

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,085 Previous Clinical Trials
1,147,282 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
~3 spots leftby Nov 2025
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