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Vitamin Supplement

Vitamin D for Sickle Cell Anemia (ViDAS-2 Trial)

Phase 2

Waitlist Available

Led By Margaret T Lee, MD

Research Sponsored by Gary M Brittenham, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 3-20 years old

Diagnosis of sickle cell disease (Hb SS, Hb SC, Hb S-Beta-thalassemia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and month 24

Awards & highlights

ViDAS-2 Trial Summary

This trial is testing whether daily oral vitamin D3 supplements can reduce the risk of respiratory complications in children and adolescents with sickle cell disease.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include elevated calcium levels which could lead to kidney stones and constipation; too much vitamin D might also cause weakness, fatigue, sleepiness, headache, loss of appetite, dry mouth and metallic taste.

ViDAS-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 20 years old.

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I have been diagnosed with sickle cell disease.

ViDAS-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Respiratory Events

Secondary outcome measures

Change in C-terminal telopeptides of Type I collagen (CTX)

Change in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)

Change in Forced Expiratory Flow at 25%-75% vital capacity (FEF25-75)

+21 more

ViDAS-2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Daily oral vitamin D3Experimental Treatment1 Intervention

Oral vitamin D3, 3,333 IU

Group II: Monthly bolus oral vitamin D3Active Control2 Interventions

Bolus oral vitamin D3, 100,000 IU

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gary M Brittenham, MDLead Sponsor

2 Previous Clinical Trials

134 Total Patients Enrolled

Margaret T Lee, MDPrincipal InvestigatorColumbia University

2 Previous Clinical Trials

134 Total Patients Enrolled

Media Library

Daily oral vitamin D3, 3,333 IU (Vitamin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04170348 — Phase 2

Sickle Cell Disease Research Study Groups: Daily oral vitamin D3, Monthly bolus oral vitamin D3

Sickle Cell Disease Clinical Trial 2023: Daily oral vitamin D3, 3,333 IU Highlights & Side Effects. Trial Name: NCT04170348 — Phase 2

Daily oral vitamin D3, 3,333 IU (Vitamin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04170348 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study include middle-aged patients?

"The age range for this particular clinical trial is 3 to 20. Out of the 691 trials available for people under 18, this one is 1533rd in terms of popularity for people over 65."

Answered by AI

What purpose does Daily oral vitamin D3, 3,333 IU serve?

"D3, 3,333 IU is frequently given to patients in the form of a pill once per day. This treatment can help with calcium levels as well as more serious conditions such as post-menopausal osteoporosis."

Answered by AI

How many people are taking part in this clinical trial?

"Presently, this clinical trial is not recruiting patients. The last update to the posting on clinicaltrials.gov was on September 29th, 2020. There are 37 other trials looking for participants that might be of interest; 2204 for respiratory tract infections and 3,333 for Daily oral vitamin D3, 3,333 IU."

Answered by AI

Has the FDA authorized taking 3,333 IU of vitamin D3 every day?

"While there is some safety data for Daily oral vitamin D3, 3,333 IU from Phase 2 trials, none of these studies have looked at efficacy yet."

Answered by AI

Are there many examples of research done on the effects of taking 3,333 IU of vitamin D3 orally every day?

"There are 37 ongoing studies on the effects of Daily oral vitamin D3, 3,333 IU. Of these trials, 15 are in Phase 3 and several are based in Rochester, Minnesota. However, there are a total of 171 locations conducting studies on this topic."

Answered by AI

Who might be the best suited candidates for this particular clinical trial?

"Up to 69 young patients with respiratory tract infections will be enrolled in this study. The majority of participants are required to meet the following two conditions: a diagnosis of sickle cell disease (Hb SS, Hb SC, Hb S-Beta-thalassemia) and an age between 3 and 20 years old."

Answered by AI

Are new participants being sought for this research?

"Presently, this trial is not searching for new patients to enroll. The clinical trial was first posted on September 15th, 2020 and was last edited 29th of the same month in 2022. There are presently 2204 studies actively searching for patients with respiratory tract infections and 37 studies for Daily oral vitamin D3, 3,333 IU admitting patients."

Answered by AI

Recent research and studies

Journal of Pediatric Hematology/OncologyJournal

Validation of a Questionnaire to Identify Respiratory Tract Infections in Children with Sickle Cell Disease

De, Aliva, Chika V. Anekwe, Meyer Kattan, Yujing Yao, Zhezhen Jin, Gary M. Brittenham, and Margaret T. Lee. 2021. “Validation of a Questionnaire to Identify Respiratory Tract Infections in Children with Sickle Cell Disease”. Journal of Pediatric Hematology/oncology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mph.0000000000002164.

Blood AdvancesJournal

Randomized Phase 2 Trial of Monthly Vitamin D to Prevent Respiratory Complications in Children with Sickle Cell Disease

Lee, Margaret T., Meyer Kattan, Ilene Fennoy, Stephen M. Arpadi, Rachel L. Miller, Serge Cremers, Donald J. McMahon, Jeri W. Nieves, and Gary M. Brittenham. 2018. “Randomized Phase 2 Trial of Monthly Vitamin D to Prevent Respiratory Complications in Children with Sickle Cell Disease”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2017013979.

Journal of Pediatric Hematology/OncologyJournal

Response to Long-term Vitamin D Therapy for Bone Disease in Children with Sickle Cell Disease

Williams, Kristen M., Margaret T. Lee, Maureen Licursi, Gary M. Brittenham, and Ilene Fennoy. 2018. “Response to Long-term Vitamin D Therapy for Bone Disease in Children with Sickle Cell Disease”. Journal of Pediatric Hematology/oncology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mph.0000000000001155.

clinicaltrials.govStudy