Vitamin D Levels In Patients Who Has Normal to Grade 2 Knee Arthroscopy Changes

This study is not yet open for participant recruitment.
Verified January 2013 by Mid Essex Hospital NHS Trust
Sponsor:
Information provided by (Responsible Party):
Dr. S R Thanthulage, Mid Essex Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01764139
First received: January 7, 2013
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

Vitamin D deficiency has long been linked to musculoskeletal pain, and many other chronic disease conditions. Vitamin D is a nutrient that functions as a hormone precursor, and wide-ranging health effects are supported by the presence of vitamin D receptors in several cell types and tissues of the body (eg, lymphocytes and monocytes, brain, heart, pancreas, intestine, and placenta).In addition to its essential role of maintaining bone health, hypovitaminosis D has been implicated in the development of serious conditions, including diabetes, various types of cancer, and cardiovascular diseases.

Vitamin D is a unique prohormone that humans obtain in small amount from food, dietary supplements and largely by endogenous skin synthesis from 7-dehydrocholesterol with sunlight exposure. This endogenous synthesis produces the form vitamin D3 (cholecalciferol).Vitamin D deficiency and insufficiency are very common in the UK. Local audit at Chelmsford has shown severe deficiency of vitamin D among chronic pain patients.

The major source of vitamin D synthesis relies on sunlight exposure which is likely to be affected by modern lifestyles, which increasingly involve working indoors during daylight hours. This may be particularly important when combined with residence in northern latitudes and a cloudy climate.The proposed pilot study aims to identify percentage of vitamin D deficiency among knee pain patients by investigating eligible patients' blood for '25 hydroxy vitamin D'.

English speaking patients whose knee pain has not been resolved following knee arthroscopy are eligible for the study. Study will be carried out at the Broomfield hospital chronic pain department.

Duration will be around 6 months.


Condition Intervention
Knee Pain
Procedure: Blood sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Vitamin D Levels In Patients Who Has Normal to Grade 2 Knee Arthroscopy Changes or Who Did Not Improve Symptoms Following Minor Knee Arthroscopic Procedures

Resource links provided by NLM:


Further study details as provided by Mid Essex Hospital NHS Trust:

Primary Outcome Measures:
  • The percentages of Vitamin D deficiency among the knee pain patients. [ Time Frame: 6months ] [ Designated as safety issue: No ]
    To identify the percentages of Vitamin D deficiency among the knee pain patients


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Knee pain patients with minimal knee changes
Male & no pregnant female age between 18-40 yrs.
Procedure: Blood sampling
Other Name: Investigtion of Vitamin D levels

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male & no pregnant female age between 18-40 yrs, who continue to experience knee pain following normal to Grade 2 knee arthroscopy findings.

Criteria

Inclusion Criteria:

  • Male & no pregnant female age between 18-40 yrs, who continue to experience knee pain following normal to Grade 2 knee arthroscopy findings.

Exclusion Criteria:

  • Any types of anatomical or neurological causes for the pain, history of seizures, regional pain syndrome, alcohol or drug abuse, and malignancy, patients with clinically significant diseases and patients who do not understand English will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764139

Locations
United Kingdom
Broomfield Hospital Not yet recruiting
Chelmsford, Essex, United Kingdom, CM1 7ET
Contact: Bruce Phillip    0124551536    mandy.austin@meht.nhs.uk   
Contact: Tracey Camburn    01245516599    tracey.camburn@meht.nhs.uk   
Principal Investigator: Subodha Thanthulage, MD,FRCAFIPP         
Sponsors and Collaborators
Dr. S R Thanthulage
  More Information

No publications provided

Responsible Party: Dr. S R Thanthulage, DR, Mid Essex Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT01764139     History of Changes
Other Study ID Numbers: 12/LO/1689, 12/LO/1689
Study First Received: January 7, 2013
Last Updated: January 8, 2013
Health Authority: United Kingdom: Health Research Authority NHS

Keywords provided by Mid Essex Hospital NHS Trust:
Minimal knee changes

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014