Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01764139
Recruitment Status : Terminated (Lack of patients with recruitment criteria)
First Posted : January 9, 2013
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. S R Thanthulage, Mid Essex Hospital NHS Trust

Tracking Information
First Submitted Date January 7, 2013
First Posted Date January 9, 2013
Last Update Posted Date March 17, 2016
Study Start Date March 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2013)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vitamin D Levels In Patients Who Has Normal to Grade 2 Knee Arthroscopy Changes
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
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.

Detailed Description

Introduction Vitamin D deficiency has recently been linked with a range of diseases including chronic pain. Range of vitamin D levels are classified as deficiency less than 50nmols, insufficient 50 to 75 nmols, and adequate 75 to 150 nmoles, excessive more than 150nmol. Vitamin D deficiency was also identified in some of the chronic pain patients who presented to our pain clinic at Broomfield hospital.

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, or increasingly working indoors during daylight hours. This may be particularly important when combined with residence in northern latitudes and a cloudy climate.

Observational and circumstantial evidence suggests that there may be a role for vitamin D treatment for some chronic pain conditions. Al-Jarallah &colleagues had showed that (25(OH) D level was 11.4 ± 6.07 ng/ml.) 92.9% were vitamin D deficient among their Kuwaiti patients with primary knee osteoarthritis (21).

Our aim is to identify how many percentages of our patients, who are having knee pain, without any major abnormal findings are deficient of vitamin D.

If this number is significant, can we supplement them to improve their pain? If we correctly supplement patients early enough, can we prevent further deterioration of their knee joint? These are some of the questions we may be able to investigate and treat.

Currently the investigations of vitamin D levels were done on patients with primary knee osteoarthritis and to assess its relation with radiological grading and functional status, but not to assess the relationship with pain.

Research Aims, hypotheses We aim to identify incidence of vitamin D deficiency among knee pain patients. If this proves significant, next step is to organise a trial to treat these patients to identify the effectiveness of adequate supplementation for relieving pain. Our aim is to investigate around 50 patients.

Recruitment English speaking patients whose knee pain has not been resolved following knee arthroscopy will be invited to the study. Sample size will be only 50 patients. Patients will explain the purpose of the study in plain English before the invitation. After giving informed consent, sample of blood will be taken for '25hydroxy vitamin D' levels. Study will be carried out at the Broomfield hospital chronic pain department.

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.

Intervention or procedure One blood sample per patient.

Data management and analysis The proportion of patients with vitamin D deficiency will be estimated from the data and the corresponding 95% confidence limits calculated using the Wilson method. The mean and standard deviation of the vitamin D level will be estimated from the data along with the corresponding 95% confidence limits obtained using a bootstrap with 999 samples. The statistical distribution of the vitamin D level will also be examined.

Primary outcome measure for the study To identify the percentages of Vitamin D deficiency among the knee pain patients

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Knee Pain
Intervention Procedure: Blood sampling
Other Name: Investigtion of Vitamin D levels
Study Groups/Cohorts Knee pain patients with minimal knee changes
Male & no pregnant female age between 18-40 yrs.
Intervention: Procedure: Blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 15, 2016)
2
Original Estimated Enrollment
 (submitted: January 8, 2013)
50
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01764139
Other Study ID Numbers 12/LO/1689
12/LO/1689 ( Other Identifier: Directory of NRES Research Ethics Committees )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. S R Thanthulage, Mid Essex Hospital NHS Trust
Study Sponsor Dr. S R Thanthulage
Collaborators Not Provided
Investigators Not Provided
PRS Account Mid Essex Hospital NHS Trust
Verification Date March 2016