SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00920621

Developed by Shray Alag, 2019.
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

Vitamin D treatment

Name: Vitamin D3

Description: 4000 IU of vitamin D3 administered orally once a day during pregnancy

Type: Dietary Supplement

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:
Asthma
Genes 66
ELOVL4 FLG COL5A1 LIFR COL5A2 TGIF1 LIG4 CDSN ERCC2 BCL11B CARMIL2 COMT SEC24C ALMS1 ARVCF NKX2-1 DOCK8 GLI2 TRAIP NFKB2 CFTR TBX21 SCN4A UFD1 GAS1 PEPD SHH BBS1 GTF2H5 PEX5 CASP8 FGF8 CARD11 FGFR1 TDGF1 PLCG2 LRBA SIK3 COX4I2 IDS PTCH1 RREB1 FOXH1 SIX3 DLL1 ADA SUFU NODAL NSUN2 GRHL2 TALDO1 NEK9 CCDC151 JMJD1C DISP1 TBX1 PGM3 SDHD CDON HIRA ZIC2 GP1BA GP1BB COL1A1 SPINK5 GP9