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Report for Clinical Trial NCT03963128
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Effectiveness of Vitamin D Supplementation to Reduce Injury and Illness in the UK Armed Forces With Specific Reference to Stress Fracture Risk Reduction
The study will comprise of an original investigation that will take the form of a prospective intervention (two matched groups) study. Condition-1 will be a vitamin D supplementation group (50.000 IU every two months), and Condition-2 will be a placebo supplementation group. The primary research aim of this project is to evaluate the effectiveness of vitamin D supplementation to reduce stress fracture risk and susceptibility to skin, soft tissue infection (SSTI) and respiratory infection in Royal Marine recruits undertaking arduous physical training in a randomised control trial (RCT). The secondary research aims are: 1. To investigate whether supplementation of vitamin D3 at a dose of 50.000 IU every two months (equivalent to 800 IU per day) is effective in reducing the risk of stress fracture and susceptibility to skin, soft tissue and respiratory infection. 2. To examine changes in vitamin D status (relative to baseline serum 25(OH)D concentration), serum PTH concentration, and markers of bone turnover in response to vitamin D3 supplementation during the winter and summer months. 3. To identify interactions between dietary intakes, physical fitness, physical characteristics (body mass, BMI, thigh girth), smoking habit, alcohol consumption, and stress fracture prevalence with serum 25(OH)D status, serum PTH concentration and markers of bone turnover in the vitamin D3 supplemented group vs. the placebo supplemented group.
NCT03963128 Stress Fracture Injury MeSH:Fractures, Stress
2 Interventions
Name: Supplementation Vitamin D3
Name: Placebo
Primary Outcomes
Measure: The effectiveness of supplementation of vitamin D3 at a dose of 50.000 IU administered every two months (equivalent of 800 IU per day) in reducing the risk of stress fracture. Time: 32 weeksSecondary Outcomes
Measure: The effectiveness of supplementation of vitamin D3 at a dose of 50.000 IU administered every two months (equivalent of 800 IU per day) in reducing the risk of susceptibility to skin infection. Time: 32 weeksMeasure: The effectiveness of supplementation of vitamin D3 at a dose of 50.000 IU administered every two months (equivalent of 800 IU per day) in reducing the risk of susceptibility to soft tissue (SSTI) infection. Time: 2018 - 2023
Measure: The effectiveness of supplementation of vitamin D3 at a dose of 50.000 IU administered every two months (equivalent of 800 IU per day) in reducing the risk of respiratory infection. Time: 32 weeks
Measure: Changes in vitamin D status (relative to baseline serum 25(OH)D concentration) in response to vitamin D3 supplementation during the winter and summer months. Time: 32 weeks
Measure: Changes in serum PTH concentration (relative to baseline concentration) in response to vitamin D3 supplementation during the winter and summer months. Time: 32 weeks
Measure: Changes in markers of bone turnover (relative to baseline concentration) in response to vitamin D3 supplementation during the winter and summer months. Time: 32 weeks
Measure: Interactions between dietary intakes, physical fitness, physical characteristics, smoking habit, alcohol consumption, and stress fracture prevalence with serum 25(OH)D status. Time: 32 weeks
Measure: Interactions between dietary intakes, physical fitness, physical characteristics, smoking habit, alcohol consumption, and stress fracture prevalence with serum PTH concentrations. Time: 32 weeks
Measure: Interactions between dietary intakes, physical fitness, physical characteristics, smoking habit, alcohol consumption, and stress fracture prevalence with markers of bone turnover. Time: 32 weeks
Purpose: Prevention
Allocation: Randomized
Factorial Assignment
There are 5 SNPs
SNPs
1 rs10741657
The specific SNPs for analysis will include: rs12785878 - 11q12 near DHCR7 (7-dehydrocholesterol reductase); rs10741657 - 11p15 near CYP2R1 (25hydroxylation); rs2282679 - 4p12 in GC (vitamin D binding protein); rs1998199 - 20q13 near STX16/NPEPL1/GNAS (associated with pseudo-hypoparathyoidism); rs6013897 - 20q13 near CYP24A1 (24 hydroxylation); and, Apa, taq, Bsm, fok1 - vitamin D receptor gene polymorphism.
2 rs12785878
The specific SNPs for analysis will include: rs12785878 - 11q12 near DHCR7 (7-dehydrocholesterol reductase); rs10741657 - 11p15 near CYP2R1 (25hydroxylation); rs2282679 - 4p12 in GC (vitamin D binding protein); rs1998199 - 20q13 near STX16/NPEPL1/GNAS (associated with pseudo-hypoparathyoidism); rs6013897 - 20q13 near CYP24A1 (24 hydroxylation); and, Apa, taq, Bsm, fok1 - vitamin D receptor gene polymorphism.
3 rs1998199
The specific SNPs for analysis will include: rs12785878 - 11q12 near DHCR7 (7-dehydrocholesterol reductase); rs10741657 - 11p15 near CYP2R1 (25hydroxylation); rs2282679 - 4p12 in GC (vitamin D binding protein); rs1998199 - 20q13 near STX16/NPEPL1/GNAS (associated with pseudo-hypoparathyoidism); rs6013897 - 20q13 near CYP24A1 (24 hydroxylation); and, Apa, taq, Bsm, fok1 - vitamin D receptor gene polymorphism.
4 rs2282679
The specific SNPs for analysis will include: rs12785878 - 11q12 near DHCR7 (7-dehydrocholesterol reductase); rs10741657 - 11p15 near CYP2R1 (25hydroxylation); rs2282679 - 4p12 in GC (vitamin D binding protein); rs1998199 - 20q13 near STX16/NPEPL1/GNAS (associated with pseudo-hypoparathyoidism); rs6013897 - 20q13 near CYP24A1 (24 hydroxylation); and, Apa, taq, Bsm, fok1 - vitamin D receptor gene polymorphism.
5 rs6013897
The specific SNPs for analysis will include: rs12785878 - 11q12 near DHCR7 (7-dehydrocholesterol reductase); rs10741657 - 11p15 near CYP2R1 (25hydroxylation); rs2282679 - 4p12 in GC (vitamin D binding protein); rs1998199 - 20q13 near STX16/NPEPL1/GNAS (associated with pseudo-hypoparathyoidism); rs6013897 - 20q13 near CYP24A1 (24 hydroxylation); and, Apa, taq, Bsm, fok1 - vitamin D receptor gene polymorphism.