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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
Name: Vitamin D3
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 gestationSecondary 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 yearsDescription: 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 visitDescription: 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 deliveryDescription: 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 yearDescription: 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 yearsDescription: Genotype at the rs12936231 SNP
Measure: Child 17q21 Genotype Time: 3 yearsPurpose: 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.