The D-BIICEP Study

NCT03253055 | Completed

• 1 other identifier: D-BIICEP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Vitamin D Deficiency

Keywords

Physical Performance; Bone; Illness; Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Seasonal Change in the Incidence of Injury in University Athletes

  1 year

• Seasonal Change in Bone Mineral Density in University Athletes

  1 year

• Seasonal Change in Bone Mineral Content in University Athletes

  1 year

• The change in vitamin D status due to participation in indoor or outdoor training in university level athletes between Autumn and Spring.

  1 year

• Change between autumn and spring and the effects of high, medium and low impact sports on bone mineral density in university athletes

  1 year

Study Arms (3)

Male Athletes

DEXA, pQCT, lifestyle questionnaire, muscular strength measurements, aerobic fitness, blood draw and finger prick test.

Radiation: DEXA; Radiation: pQCT; Other: Lifestyle Questionnaire; Other: Aerobic Fitness; Other: Muscular Strength; Biological: Blood draw and finger prick test; Other: Muscular Power

Female Athletes

DEXA, pQCT, lifestyle questionnaire, muscular strength measurements, aerobic fitness, blood draw and finger prick test.

Radiation: DEXA; Radiation: pQCT; Other: Lifestyle Questionnaire; Other: Aerobic Fitness; Other: Muscular Strength; Biological: Blood draw and finger prick test; Other: Muscular Power

Controls

DEXA, pQCT, lifestyle questionnaire, muscular strength measurements, aerobic fitness, blood draw and finger prick test.

Radiation: DEXA; Radiation: pQCT; Other: Lifestyle Questionnaire; Other: Aerobic Fitness; Other: Muscular Strength; Biological: Blood draw and finger prick test; Other: Muscular Power

Interventions

DEXA RADIATION

Dual energy X-ray absorptiometry (DEXA): a total of two scans will be performed, one for the assessment of whole body bone mineral density and body composition, and the other scan is performed to specifically assess fracture risk by scanning the hip and femoral head. Effective exposure doses for these scans are \~8uSv and \~4uSv respectively.

Also known as: DXA

Controls; Female Athletes; Male Athletes

pQCT RADIATION

A total of one scan will be performed on the non-dominant Tibia, the effective exposure dose will be between 1.5-1.8uSV.

Controls; Female Athletes; Male Athletes

Lifestyle Questionnaire OTHER

Participants are required to record their lifestyle, diet (5-day self reported), physical activity (IPAQ questionnaire), injury and illness incidence.

Controls; Female Athletes; Male Athletes

Aerobic Fitness OTHER

Aerobic fitness will be tested using a VO2 max exercise protocol using a stationary cycle ergometer, the participants will be expected to perform this to maximal effort or exhaustion.

Controls; Female Athletes; Male Athletes

Muscular Strength OTHER

Muscular strength of the knee extensor and handgrip muscles will be determined using an Isokinetic Dynamometer and a handgrip dynamometer respectively.

Controls; Female Athletes; Male Athletes

Blood draw and finger prick test BIOLOGICAL

15ml of whole blood will be collected for the measurement of fasting serum 25(OH)D levels, parathyroid hormone, C-terminal telopeptide (CTX) and full blood count

Controls; Female Athletes; Male Athletes

Muscular Power OTHER

Muscular power will be determined using an optical measurement system consisting of a transmitting and receiving bar to determine jump height through the interpretation of jump flight of the participant (reported in cm). The equipment used is an Optojump.

Controls; Female Athletes; Male Athletes

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from the university population in Surrey during term-time

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (2)

Surrey Human Performance Institute

Guildford, Surrey, GU27AD, United Kingdom

Location

University of Surrey

Guildford, Surrey, GU27XH, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 20543748 BACKGROUND

• 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.

  PMID: 23410885 BACKGROUND

• 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.

  PMID: 25277808 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and Serum samples obtained at baseline and visit 2

MeSH Terms

Conditions

Vitamin D Deficiency; Wounds and Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Susan Lanham-New, Ph.D

  Head, Department of Nutritional Scienes

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Fellow

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 17, 2017
• Study Start: February 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

GB (2)