Vitamin D Deficiency Clinical Trial
— D-BIICEPOfficial title:
The Interrelationship Between Vitamin D, Bone, Illness, Injury and Its Impact on Exercise Performance
NCT number | NCT03253055 |
Other study ID # | D-BIICEP |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2018 |
Est. completion date | July 1, 2018 |
Verified date | November 2018 |
Source | University of Surrey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Athletes and active individuals have been identified as an at-risk group for a low vitamin D
status, specifically those residing in countries of higher latitude (such as the United
Kingdom). This especially applies to those who train indoors for their sport, this is because
Vitamin D is primarily produced following skin exposure to ultraviolet B (UVB) exposure.
Vitamin D is essential for the maintenance of optimal bone and musculoskeletal health. It has
also been suggested to play a role in the prevention of illness incidence, such as in upper
respiratory tract infections (URTI). More recent research has indicated that an improved
Vitamin D status may also play a role in enhancing exercise performance. Therefore, having a
poor vitamin D status could negatively impact athletic training and competition. The purpose
of this study is to evaluate the prevalence of vitamin D deficiency in university athletes
and inactive controls in spring and autumn.
During this study the subjects will be asked to visit the labs on two occasions, at the
beginning of the study for baseline measurements, and again on two occasions at the end of
the study. Participants will have the following outcomes assessed: Sport performance
(vertical jump height, muscular strength and aerobic fitness), peripheral Quantitative
Computed Tomography (pQCT) scan of the bone mineral composition of the tibia, total body
composition via Dual Energy X-ray Absorptiometry (DEXA),total and hip/femoral head bone
mineral density and content to assess fracture risk via DEXA. Serum 25(OH)D levels (≈15ml of
whole blood will be collected for these measurements. Dietary intake using self-reported food
diaries. In addition illness and injury incidence will be recorded daily throughout the study
in a booklet provided to the participants.Throughout the trial, the participants will be
contacted via telephone/ email on a monthly basis to discuss any issues and maintain good
communication.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 1, 2018 |
Est. primary completion date | July 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: University athlete inclusion criteria: - Male or female - Aged 18-30 - Regularly train/compete for Team Surrey Basketball, Boat Club, Swimming and Waterpolo, Netball or Rugby (for more than 4 hours/week) - In good physical health - Have a BMI >18 kg/m2 - Able to provide written informed consent Control group inclusion criteria: - Male or Female - Age 18-30 - Do not use sun beds/ will not be going on a sun holiday/ returning home to a traditional sun holiday location between February 2017 and October 2017. This is because the results will be used to represent the Vitamin D status of young sporting individuals residing within the UK during these seasons. - Do not take supplements containing Vitamin D - Do not compete for Team Surrey and exercise less than 150 minutes / week. - BMI: 18 - 30 kg/m2 Exclusion Criteria: - Currently receiving treatment for medical conditions that are likely to affect vitamin D metabolism - Hypercalcaemia (>2.5mmol/L) - Regular use of sun-beds - Having a sun holiday one month prior to commencing the study or plans for a sun holiday within the study period or will be returning home to a sun holiday location. - Use of vitamin supplements containing vitamin D (if the prospective participants agrees to stop Vitamin D supplementation to join the study, a wash-out period of 8 weeks prior to commencing the trial would be acceptable). - Excess alcohol intake for participants aged 18 years (> 21 units for males, > 14 units for females per week, as per Government guidelines) - Those under dietary restriction (except vegetarianism) or following a weight-reducing diet. - Clinically significant haematological abnormalities other than mild anaemia (Hb <12.0g/dl) - Active malignancy - Pregnant or planning a pregnancy during the study period |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Surrey Human Performance Institute | Guildford | Surrey |
United Kingdom | University of Surrey | Guildford | Surrey |
Lead Sponsor | Collaborator |
---|---|
University of Surrey |
United Kingdom,
Close GL, Leckey J, Patterson M, Bradley W, Owens DJ, Fraser WD, Morton JP. The effects of vitamin D(3) supplementation on serum total 25[OH]D concentration and physical performance: a randomised dose-response study. Br J Sports Med. 2013 Jul;47(11):692-6. doi: 10.1136/bjsports-2012-091735. Epub 2013 Feb 14. — View Citation
Farrokhyar F, Tabasinejad R, Dao D, Peterson D, Ayeni OR, Hadioonzadeh R, Bhandari M. Prevalence of vitamin D inadequacy in athletes: a systematic-review and meta-analysis. Sports Med. 2015 Mar;45(3):365-78. doi: 10.1007/s40279-014-0267-6. Review. — View Citation
Halliday TM, Peterson NJ, Thomas JJ, Kleppinger K, Hollis BW, Larson-Meyer DE. Vitamin D status relative to diet, lifestyle, injury, and illness in college athletes. Med Sci Sports Exerc. 2011 Feb;43(2):335-43. doi: 10.1249/MSS.0b013e3181eb9d4d. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seasonal Change in the Number of Participants with Deficiency in Vitamin D (according to government cut-off points in the UK and USA) in University Athletes and their Healthy Controls. | This will be assessed by measuring serum 25(OH)D levels in participants during Autumn and Spring. Vitamin D status will be measured in nmol/L | 1 year | |
Secondary | Seasonal Change in the Incidence of Injury in University Athletes | Self reported questionnaire | 1 year | |
Secondary | Seasonal Change in Bone Mineral Density in University Athletes | mg/cm | 1 year | |
Secondary | Seasonal Change in Bone Mineral Content in University Athletes | mg/cm | 1 year | |
Secondary | The change in vitamin D status due to participation in indoor or outdoor training in university level athletes between Autumn and Spring. | hours and nmol/L | 1 year | |
Secondary | Change between autumn and spring and the effects of high, medium and low impact sports on bone mineral density in university athletes | mg/cm | 1 year | |
Secondary | Changes from baseline in muscular power throughout an academic sporting season | Vertical jump: cm | 1 year | |
Secondary | Changes from baseline in muscular strength throughout an academic sporting season | hand-grip strength: kg, knee extensor muscular strength: nM | 1 year | |
Secondary | Changes from baseline in aerobic fitness throughout an academic sporting season | ml/kg/min-1 | 1 year | |
Secondary | Change from baseline in the incidence of injury and illness and its correlation with vitamin D status | Days of illness reported or missed training due to injury | 1 year |
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