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Report for Clinical Trial NCT00920621

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.

NCT00920621 Asthma
MeSH:Asthma
HPO:Asthma

2 Interventions

Name: Vitamin D 3 cholecalciferol

Description: Dosage form oral Dosage 4000IU Vitamin D 3 cholecalciferol
Type: Dietary Supplement
Group Labels: 1

Vitamin D treatment

Name: Vitamin D3

Description: 4000 IU of vitamin D3 administered orally once a day during pregnancy
Type: Dietary Supplement
Group Labels: 2

Vitamin D treatment placebo


Primary Outcomes

Description: Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months. *For some variables the "negative" count incorporates "negative and indeterminate."

Measure: Asthma or Recurrent Wheeze in First 3 Years of Life

Time: First 3 years of life.

Description: Maternal serum 25-hydroxyvitamin D measurement at third trimester during pregnancy

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

Time: 32-38 weeks gestation

Secondary Outcomes

Description: Child positive-specific IgE tests from blood collection at 3 year visit.

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

Time: 3 years

Description: Child serum 25-hydroxyvitamin D measurement from blood collection at 1 year visit.

Measure: Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.

Time: 1 year visit

Description: Parental report of physician diagnosis of eczema with rash in typical distribution in the child's first 3 years of life ascertained from questionnaires administered every 3 months. *For some variables the "negative" count incorporates "negative and indeterminate."

Measure: Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life.

Time: Child's first 3 years of life.

Description: Parental report of physician diagnosis of lower respiratory tract infection (LRI) in the child's first 3 years of life. LRI defined as physician diagnosed bronchitis, bronchiolitis, croup, or pneumonia ascertained from questionnaires administered every 3 months.

Measure: Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.

Time: Child's first 3 years of life.

Description: Child serum 25-hydroxyvitamin D measurement from blood collection at 3 year visit.

Measure: Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.

Time: Blood collection at childs' 3 year visit.

Description: Any allergic sensitization in the child's first 3 years of life. *For some variables the "negative" count incorporates "negative and indeterminate."

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

Time: Child's first 3 years of life.

Description: Mass Spec Vitamin D value from cord blood at delivery

Measure: Mass Spec Vitamin D Value From Cord Blood at Delivery

Time: Blood collection at delivery

Description: Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year one visit.

Measure: Sphingolipid Profile

Time: 1 year

Description: Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year three visit.

Measure: Sphingolipid Profile

Time: 3 years

Description: Genotype at the rs12936231 SNP

Measure: Child 17q21 Genotype

Time: 3 years

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12936231

Genotype at the rs12936231 SNP.

We will compute hazard ratios for the reduction in asthma/wheeze risk associated with prenatal supplementation, stratified by rs12936231.

rs12936231 is a functional SNP influencing expression of ORMDL3, and given the role of ORMDL3 as a key sphingolipid biosynthesis regulator, we will subsequently investigate the relative abundance of sphingolipids between those in the vitamin D Intervention arm and those in the placebo group, stratified by 17q21 genotype.

Finally we will identify interactions between prenatal vitamin D supplementation, rs12936231 genotype and sphingolipid metabolism in the risk of asthma/wheeze by age three.



HPO Nodes


HPO: