Vitamin D for Sickle Cell Anemia

(ViDAS-2 Trial)

Overseen By Margaret T Lee, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Columbia University

Must not be taking: Corticosteroids, Anticonvulsants, Thiazides, Lithium

Disqualifiers: Rickets, Hypercalcemia, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 24 months

69 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if vitamin D3 can lower lung issues in kids with sickle cell disease. It compares different dosing schedules to see which works better. The goal is to find a simple, low-cost way to help these children stay healthier. Vitamin D has been studied for its potential to reduce respiratory complications in children with sickle cell disease due to its ability to fight infections and support the immune system.

Research Team

Gary M Brittenham, MD

Principal Investigator

Columbia University

Margaret T Lee, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for children and adolescents aged 3-20 with sickle cell disease. It's not for those on chronic blood transfusions, using certain seizure meds, unable to consent or follow the study plan, with rickets or high calcium conditions, liver/kidney disease, unstable pulmonary meds within 3 months prior to the study, current corticosteroid use (except inhaled), or in another clinical trial.

Inclusion Criteria

I am between 3 and 20 years old.

I have been diagnosed with sickle cell disease.

Exclusion Criteria

I am on a long-term treatment that involves receiving blood transfusions.

I am willing and able to follow the clinical trial's requirements.

I am currently taking corticosteroids, but not through inhalation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive daily oral vitamin D3 or monthly bolus vitamin D3 for 24 months

24 months

Monthly visits (in-person) for monitoring and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Bolus oral vitamin D3, 100,000 IU
• Daily oral vitamin D3, 3,333 IU
• Placebo oral tablet

Trial Overview The study tests if daily vitamin D supplements can lower respiratory issues in young people with sickle cell disease. Participants will either take a daily dose of vitamin D3 (3333 IU) or a monthly bolus dose (100000 IU), compared to a placebo group. The goal is to cut respiratory complications by half within one year.

Participant Groups

Group I: Daily oral vitamin D3 Experimental Treatment 1 Intervention

Oral vitamin D3, 3,333 IU

Group II: Monthly bolus oral vitamin D3 Active Control 2 Interventions

Bolus oral vitamin D3, 100,000 IU

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Gary M Brittenham, MD

Lead Sponsor

Trials

3

Recruited

140+