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Knee PainNCT01764139

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

An observational study of Knee Pain, run by Dr. S R Thanthulage at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Knee Pain
What is being tested?
Blood sampling
Type of treatment
Surgery or procedure
How many people
2 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2013to Mar 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Broomfield Hospital

    Chelmsford, Essex, CM1 7ET

Other trials in United Kingdom

About this study

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

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.

Read more

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.

Read the 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

Conditions
Knee Pain
Being tested
Blood sampling
Keywords
Minimal knee changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplingProcedure or surgery

    Also called Investigtion of Vitamin D levels

Study groups in NCT01764139
Study groupRoleWhat they receive
Knee pain patients with minimal knee changesMale \& no pregnant female age between 18-40 yrs.
Receives: Procedure: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

Why it stopped: Lack of patients with recruitment criteria

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01764139
Sponsor's protocol ID
12/LO/1689
Other IDs
12/LO/1689
Status last verified
Mar 2016
First submitted
7 Jan 2013
Last updated
17 Mar 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Pain, run by Dr. S R Thanthulage at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of patients with recruitment criteria). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentages of Vitamin D deficiency among the knee pain patients. (time frame: 6months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.

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