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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
Pivotal 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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,842,590 Total Patients Enrolled
43 Trials studying Asthma
219,300 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,791,422 Total Patients Enrolled
282 Trials studying Asthma
113,547 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
~54 spots leftby Dec 2025
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