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

This study has been terminated.
(Lack of patients with recruitment criteria)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764139
First Posted: January 9, 2013
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. S R Thanthulage, Mid Essex Hospital NHS Trust
  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: Prospective
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 Dr. S R Thanthulage, Mid Essex Hospital NHS Trust:

Primary Outcome Measures:
  • The percentages of Vitamin D deficiency among the knee pain patients. [ Time Frame: 6months ]
    To identify the percentages of Vitamin D deficiency among the knee pain patients


Enrollment: 2
Study Start Date: March 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764139


Locations
United Kingdom
Broomfield Hospital
Chelmsford, Essex, United Kingdom, CM1 7ET
Sponsors and Collaborators
Dr. S R Thanthulage
  More Information

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 ( Other Identifier: Directory of NRES Research Ethics Committees )
First Submitted: January 7, 2013
First Posted: January 9, 2013
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by Dr. S R Thanthulage, Mid Essex Hospital NHS Trust:
Minimal knee changes

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