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Vitamin Supplement

Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART Trial)

Phase 3

Waitlist Available

Led By Scott T Weiss

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up mother at 32-38 weeks gestation, child's first 6 years of life

Awards & highlights

VDAART Trial Summary

This trial found that vitamin D supplementation during pregnancy prevented asthma in the women's children.

Who is the study for?

This trial is for pregnant women aged 18-39, who speak English or Spanish and have a personal or partner's history of asthma, eczema, or allergic rhinitis. They must be 10-18 weeks pregnant and not smoke. Women using assisted reproduction techniques, already taking high doses of vitamin D3 supplements, with chronic conditions, or expecting multiples cannot join.Check my eligibility

What is being tested?

The study tests if giving Vitamin D (cholecalciferol) to pregnant women can prevent their children from developing asthma. Participants will receive the supplement throughout pregnancy until their child turns three years old.See study design

What are the potential side effects?

Vitamin D supplementation is generally safe but may cause side effects like nausea, constipation, weakness, serious allergic reactions in rare cases; however specific risks related to this trial are not detailed.

VDAART Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mother at 32-38 weeks gestation, child's first 6 years of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mother at 32-38 weeks gestation, child's first 6 years of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and mother at 32-38 weeks gestation, child's first 6 years of life for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.

Asthma or Recurrent Wheeze in First 3 Years of Life

Secondary outcome measures

Any Allergic Sensitization in the Child's First 3 Years of Life.

Child 17q21 Genotype

Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.

+7 more

VDAART Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Vitamin D treatmentExperimental Treatment2 Interventions

vitamin D treatment plus prenatal multivitamins

Group II: placeboPlacebo Group1 Intervention

placebo plus prenatal multivitamins

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin D 3 cholecalciferol

2009

N/A

~50

Vitamin D3

2011

Completed Phase 4

~3590

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,611 Previous Clinical Trials

11,469,643 Total Patients Enrolled

41 Trials studying Asthma

215,100 Patients Enrolled for Asthma

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,309,766 Total Patients Enrolled

276 Trials studying Asthma

111,675 Patients Enrolled for Asthma

Scott T WeissPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Vitamin D3 cholecalciferol (Vitamin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT00920621 — Phase 3

Asthma Research Study Groups: Vitamin D treatment, placebo

Asthma Clinical Trial 2023: Vitamin D3 cholecalciferol Highlights & Side Effects. Trial Name: NCT00920621 — Phase 3

Vitamin D3 cholecalciferol (Vitamin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00920621 — Phase 3

Frequently Asked Questions

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

Are patients currently being sought for participation in this research?

"The clinical trial hosted on clinicaltrials.gov is not currently enrolling patients. Although, this study was most recently updated on March 7th, 2022, it is not looking for patients anymore. There are 322 other clinical trials actively searching for participants right now."

Answered by AI