There is one clinical trial.
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 Conditions
- Stress Fracture
- Injury
Interventions
- Dietary Supplement: Supplementation Vitamin D3
- Dietary Supplement: Placebo
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.
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 weeks
Secondary 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 weeks
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 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