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.
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.
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 group | Role | What they receive |
|---|---|---|
| Knee pain patients with minimal knee changes | Male \& 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.
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.
- First posted9 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Lack of patients with recruitment criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dr. S R Thanthulage
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. S R Thanthulage, Mid Essex Hospital NHS Trust
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01764139
- Acronym / sponsor ID
- 12/LO/1689
- Conditions
- Knee Pain
- Keywords
- Minimal knee changes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of patients with recruitment criteria
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dr. S R ThanthulageUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee pain patients with minimal knee changes | – | Procedure: Blood samplingMale \& no pregnant female age between 18-40 yrs. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Male \& no pregnant female age between 18-40 yrs, who continue to experience knee pain following normal to Grade 2 knee arthroscopy findings.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingAlso: Investigtion of Vitamin D levels | Procedure or surgery | Knee pain patients with minimal knee changes |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Lack of patients with recruitment criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.