SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02043223

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Stopping Postpartum Vitamin A Supplementation: Are we Missing Concealed Benefit?

The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.

NCT02043223 Vitamin A Deficiency
MeSH: Night Blindness Vitamin A Deficiency
HPO: Low levels of vitamin A Nyctalopia

4 Interventions

Name: Vitamin A (<3-day postpartum)

Description: Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum.

Type: Dietary Supplement

Early postpartum vitamin A suppl.

Name: Vitamin A (6 wk postpartum)

Description: Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.

Type: Dietary Supplement

Late postpartum vitamin A suppl.

Name: Vitamin A (<3-day and 6 wk postpartum)

Description: 200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum

Type: Dietary Supplement

Early Early & Early & late postpartum vitamin A suppl

Name: Placebo

Description: Placebo supplementation, both at <3-day and 6-wk postpartum.

Type: Dietary Supplement

No postpartum vitamin A suppl.


Primary Outcomes

Description: immune regulators in breast milk e.g. B-cell activating factor (BAFF); IL-7; Lactoferrin; sCD14, sIgA and TGF-beta levels at three time points- < 3-day postpartum (before 1st dose of supplementation) 7 wk postpartum (1wk after 2nd dose of supplementation) 15 wk postpartum

Measure: Breast milk immune regulators

Time: Four months

Secondary Outcomes

Description: Mitogen stimulated whole blood IL-10, IL-13, IFN-gamma, IL-21 and IL-17 responses at two time points- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 15 wk of age (1wk after three doses of pentavalent vaccination)

Measure: Infant T helper cell immune responses

Time: Four months

Description: Tall like receptor (TLR)-4 and TLR9 agonist stimulated whole blood TNF-alpha and IL-10 and IFN-alpha responses at two time points- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 15 wk of age (1wk after three doses of pentavalent vaccination)

Measure: Infant innate immune responses

Time: Four months

Description: Hepatitis B and Tetanus Toxoid specific plasma cell IgG responses at 15 wk of age (1wk after three doses of pentavalent vaccination) And Hepatitis B and Tetanus Toxoid specific IgG in plasma and Polio (3 serotypes) specific secretory IgA (sIgA) in stool at two time points- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 15 wk of age (1wk after three doses of pentavalent vaccination)

Measure: Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses

Time: Four months

Description: Next generation sequencing (NGS) of bacterial 16s rDNA (+qPCR) in extracted stool samples and assessment of infant gut inflammatory markers e.g. human β-defensin-2 (HBD2); Neopterin; α-1-antitrypsin (AAT); neutrophil gelatinase-associated lipocalin (NGAL)-2 and S100A at two time points- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 15 wk of age (1wk after three doses of pentavalent vaccination)

Measure: Relative abundance of infant gut microbial community and gut inflammatory markers

Time: Four months

Other Outcomes

Description: Infant plasma vitamin A status at 7 wk and 15 wk of age

Measure: Infant vitamin A status

Time: Four months

Description: Infant Weight-for-Age z-score (WAZ) at 7 wk and 15 wk of age

Measure: Infant growth

Time: Four months

Description: Infant morbidity status up to four months of age

Measure: Infant morbidity

Time: Four months

Description: Plasma Retinol Binding Protein (RBP) and breast milk vitamin A level at two time points- < 3-day postpartum (before 1st dose of supplementation) 15 wk postpartum

Measure: Mother vitamin A status

Time: Four months

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 S100A

human β-defensin-2 (HBD2); Neopterin; α-1-antitrypsin (AAT); neutrophil gelatinase-associated lipocalin (NGAL)-2 and S100A at two time points- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 15 wk of age (1wk after three doses of pentavalent vaccination). --- S100A ---



HPO Nodes


HPO:
Low levels of vitamin A
Genes 5
MST1 TCF4 BCO1 FARSB GPR35
Nyctalopia
Genes 313
SNRNP200 PDE6A IDH3A PHYH ABCA4 ZNF408 CNGB3 GUCA1A SEMA4A AP3D1 PEX7 IMPG2 CABP4 RHO PCARE RHO CACNA1F RP1 RDH5 POU3F4 IFT88 PDE6B RGR ZNF513 ATF6 SLC7A14 TTC8 COG4 PROM1 CHM ND4 REEP6 POMGNT1 NEK2 CA4 RHO CA4 LRIT3 GRM6 RLBP1 RHO PDE6H SCAPER PCARE TRNS2 AGBL5 RLBP1 HK1 TRNT1 SNRNP200 BBS4 CRB1 EYS TRNQ C8ORF37 SLC24A1 DRAM2 PRPF4 ARL3 CRX ARL6 RDH12 TRPM1 RBP3 IFT172 PRPH2 ARL3 RP1 AIPL1 RLBP1 CACNA2D4 PRPH2 SPATA7 NR2E3 PEX7 SEMA4A ARL2BP AHR FLVCR1 SLC24A1 PRPF31 GUCA1A PRCD RLBP1 RPE65 CABP4 CDH23 POC1B UNC119 PRPH2 LRAT PITPNM3 CDHR1 DHDDS CDHR1 NMNAT1 C1QTNF5 TRNF IFT140 GRM6 OPN1MW PEX5 CLRN1 RP2 REEP6 PRPF4 CEP78 MMP19 PRPH2 FSCN2 CNGA1 FGFR2 TULP1 TRAPPC9 ROM1 BBS2 CFAP410 PRPF3 RHO AIPL1 PRPF31 PDE6G ITM2B MAK RPGRIP1 PRPH2 LRAT CACNA1F NMNAT1 CRX GRK1 PRPF8 VPS13B GUCA1B PEX26 POMGNT1 ND6 CERKL CLRN1 KIAA1549 CRB1 CNGA1 PEX13 PEX12 OPN1LW TOPORS GNAT1 USH2A ND5 OAT CNGA3 RAB28 PEX3 CWC27 CFAP410 USH2A IMPDH1 USH1G ABCA4 C8ORF37 FLVCR1 CLRN1 LRAT TRNH NR2E3 PRPF6 ZNF408 ADAM9 PEX6 PRPH2 PROM1 RAX2 HGSNAT ARL3 RP2 PRPH2 SEMA4A BEST1 HADHA TRNL1 PDZD7 IDH3B C8ORF37 CLRN1 TUB GRK1 MYO7A DRAM2 RHO ABCA4 PEX2 PROM1 KCNV2 RP9 CHM PEX10 CACNA1F ZNF513 TRNS2 ARHGEF18 CRX RP9 GNB3 MFN2 CYP4V2 PDE6A KLHL7 RBP3 OAT C8ORF37 NRL MYO7A EYS TULP1 RDH5 RBP3 NR2E3 TRNS1 SAG PEX11B NYX RPE65 MAK AHI1 IMPDH1 MFRP HARS1 RPGR BEST1 AGBL5 TTC8 TULP1 CRX CNNM4 DHX38 USH1C KCNJ13 COX1 AIPL1 FAM161A TTLL5 ELOVL4 SAG NRL STIM1 HSD3B7 GNAT1 CLRN1 PCYT1A TRPM1 SAG ND1 IMPG2 ARSG CACNA2D4 GNB3 SEMA4A PRPF3 TRNW GPR179 CNGB1 COX3 TTPA PEX14 GUCY2D ABCA4 GNAT1 PDE6B ADGRV1 PEX1 PEX16 RIMS1 AHR CIB2 KIZ ROM1 COX2 PCDH15 WHRN GPR179 BEST1 ARL6 RLBP1 PROM1 SPATA7 HBB PHYH PRPH2 MERTK PEX19 NYX GUCY2D PDE6B MERTK SLC7A14 ROM1 PDE6G CDHR1 ARHGEF18 SAG FAM161A GGCX MVK MYO6 OFD1 FSCN2 IFT172 PRPF8 HGSNAT RPGR CNGB1 LRIT3 GUCY2D