NCT01764139

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

January 7, 2013

Last Update Submit

March 15, 2016

Conditions

Keywords

Minimal knee changes

Outcome Measures

Primary Outcomes (1)

  • The percentages of Vitamin D deficiency among the knee pain patients.

    To identify the percentages of Vitamin D deficiency among the knee pain patients

    6months

Study Arms (1)

Knee pain patients with minimal knee changes

Male \& no pregnant female age between 18-40 yrs.

Procedure: Blood sampling

Interventions

Also known as: Investigtion of Vitamin D levels
Knee pain patients with minimal knee changes

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Broomfield Hospital

Chelmsford, Essex, CM1 7ET, United Kingdom

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 9, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations