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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

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 138
DNAH9 COL5A2 DNAH11 NFKB2 TDGF1 DDX41 SPAG1 ARMC4 GP1BA GAS2L2 CCDC151 ERCC2 TNF SPINK5 GP1BB GAS1 TGIF1 CCL11 CDON DLL1 CFAP221 PTGER2 TBX21 LRBA RSPH4A CFTR FLG NME8 DNAAF4 ZIC2 SCGB3A2 CCDC65 SDHD ADRB2 TBX1 GP1BB SIX3 IDS NODAL NSUN2 ELOVL4 PEPD CARMIL2 CFAP300 FGF8 GP9 FOXJ1 DNAI1 CASP8 DOCK8 CCDC151 DISP1 IL13 CCNO ALMS1 RSPH1 CCDC39 STK36 MUC7 NOD2 CARD11 CCDC28B DNAL1 DNAH1 ZMYND10 RSPH3 RSPH9 MS4A2 PLA2G7 HNMT DRC1 NKX2-1 SHH COL1A1 CCDC103 SPINK5 FGFR1 DNAAF3 MTOR HIRA LRRC56 LRRC6 GAS8 CFAP298 NEK9 CCDC40 IL4R PGM3 DOCK8 DNAAF2 GLI2 RREB1 TGFB1 PTCH1 GRHL2 SIK3 SCN4A BBS1 TALDO1 DNAAF1 NKX2-1 OFD1 TRAIP PLCG2 HLA-G COL5A1 ALMS1 DNAI2 BCL11B LIG4 GTF2H5 PGM3 ARVCF PEX5 CDSN SEC24C DNAAF6 DNAH5 CCDC114 ADA PLA2G7 JMJD1C DNAJB13 RPGR FOXH1 ALOX5 TTC25 FCGR2A TBX1 COMT COX4I2 UFD1 SPEF2 SUFU DNAAF5 LIFR MCIDAS HYDIN