Knee OsteoarthritisNCT02293889
Impact of Physical Activity and Vitamin D on Osteoarthritic Knee Pain
A study testing Vitamin D3 2000IU/daily 3 months and PA intervention People with Osteoarthritis Walking Programme in people with Knee Osteoarthritis, run by Newcastle University at 2 sites in United Kingdom.
Trial summary
Knee Osteoarthritis (KOA) is a major cause of pain and disability, particularly in those of increasing age and body fat. As there are no very effective therapies for KOA, disease often progresses until knee replacement surgery is needed. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Vitamin D3 2000IU/daily 3 months and PA intervention People with Osteoarthritis Walking Programme
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2015to Jul 2016
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CROSS SECTIONAL STUDY
- Obese: BMI 30-40kg/m2 as defined by WHO criteria
- Older adults: 50 - 70 years
- OA of the knee according to ACR Guidelines on symptomatic Knee OA criteria (using history and physical examination:
- Pain in the knee
- AND 3 OF THE FOLLOWING:
Show all 19Show fewer
- Over 50 years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- Bony tenderness
- Bony enlargement
- No palpable warmth of synovial
- Good understanding of written and spoken English (as no translation services will be available to this study).
- PILOT STUDY
- All of the inclusion criteria for the cross-sectional study (above), plus:
- Low objectively measured levels of Vitamin D, defined as:
- Insufficient (25-50nmol/L), excluding deficient (<25 nmol/L), the 25OHD concentration at which symptoms as a result of Vitamin D deficiency commonly occur.
- Low PA recorded from accelerometers defined as:
- <30min/week of moderate PA, <15min/week vigorous PA (2credit of moderate activity) defined as being 'inactive' by UK government guidelines. Activities only counted if they occurred in >10mins bouts. Activity was defined as moderate if it made the participant 'breathe faster, feel warmer or sweat' and increased heart rate. Activities identified as moderate included: brisk walking, cycling, gardening, housework, DIY, climbing stairs and carrying heavy loads.
Who cannot join
- CROSS-SECTIONAL STUDY
- Any other type of arthritic condition, e.g. RA, Fibromyalgia, Ankylosing Spondylitis, Gout, Lupus, Paget's Disease, Polymyalgia rheumatic (PMR), Psoriatic arthritis, Scleroderma, Sjogrens Syndrome
- Currently taking part in a PA/exercise regime
- Taking Vitamin D, cod liver oil or Calcium capsules/supplements (topical/oral/intravenous, prescribed/non-prescribed) above 10µg/day of vitamin D and/or 500µg/day of calcium.
- Taking part in another intervention/trial (depending on researchers discretion)
- Chronic alcohol abuse (> 21 (women) and 28 (men) SI units/week
Show all 32Show fewer
- PILOT STUDY
- The same exclusion criteria as the cross-sectional study, plus:
- Conditions which can interfere with Vitamin D supplement adsorption:
- Malabsorption syndromes: e.g. cystic fibrosis, celiac disease, whipples disease, Crohns Disease, Bypass Surgery, short bowel syndrome,
- Diagnosed restrictive eating disorder
- Hypercalcaemia (albumin-adjusted plasma calcium > 2.60 mmol/l)
- Hypocalcaemia (albumin-adjusted plasma calcium < 2.15 mmol/l)
- Renal Stage 4-5 Chronic Kidney Disease: GFR < 30 ml/min/1.73m2
- Primary hyperparathyroidism
- Conditions which can affect normal baseline levels of vitamin D:
- Current pregnancy, delivery of child/breast feeding 1 year prior to recruitment
- Holiday with significant sunlight exposure (specified by list of sunny destinations) in the last 3 months and plans for holidays to sunny/skiing destinations for the duration of the study.
- Current Anticonvulsant drug therapy
- Current Glucocorticoid use
- Current HIV/treatment with Antiretroviral drugs
- Current anti-oestrogen (aromatase inhibitors, oestrogen receptor inhibitors and selective oestrogen receptor moderators) such as used to treat breast cancers
- Those currently taking cytostatic/anti-tumour drugs
- Granulomatous disorders: sarcoidosis, TB, Lymphomas
- Current conditions which may be made worse/prompts complications of by vitamin D consumption
- Chronic Renal Disease: stage 4 and 5 (see above)
- Liver disease
- Histoplasmosis
- hyperparathyroidism
- Hypocalcaemia or hypercalcemia (as defined above)
- Lymphoma
- Current/recent (in the last 6 months) supplementation(topical/oral/intravenous, prescribed and non-prescribed) with: Phosphorous, >10µg/day Vitamin D and >500mg/day Calcium
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Aintree University Hospital
Liverpool, L9 7AL
North Tyneside General Hospital
Newcastle upon Tyne, NE29 8NH
About this study
Official title: The Impact of Physical Activity and Vitamin D on Osteoarthritic Knee Pain in Older Obese People
Knee Osteoarthritis (KOA) is a major cause of pain and disability, particularly in those of increasing age and body fat. As there are no very effective therapies for KOA, disease often progresses until knee replacement surgery is needed. It has been observed Vitamin D and Physical Activity (PA) levels are lower in those with KOA, increased age and body fat. As the relationship between KOA, Vitamin D and PA levels are not clearly understood, this study aims to explore these relationships and the acceptability/feasibility of PA and Vitamin D interventions in those who would likely to benefit from these interventions.
200-300 people, 50-70 years, BMI 30-40kg/m2, meeting American College of Rheumatology (ACR) KOA Guidelines, will be recruited from North Tyneside and Liverpool Hospital trusts November 2014-January 2016 to participate in a single cross-sectional study visit, which will measure: Vitamin D/Calcium serum levels, BMI/Body Fat, mobility, Quality of life and pain (by questionnaire), and PA levels.
Read more
Those participants with insufficient Vitamin D levels (25-50nmol/L) and PA levels (<30min moderate PA/week), will be invited to take part in a 3 month pilot RCT study.
>64 people will be recruited for the pilot RCT and equally randomly allocated to 1 of 4 intervention groups: Vitamin D (1 capsule a day: 2000IU), Placebo (identical capsule: 1 a day), PA (online PA programme) and PA and Vitamin D. Additionally at the end of the 12 week study visit, up to 20 participants will be invited to take part in a qualitative interview exploring their experience during the two studies.
Read the detailed description
The primary aim of this project is to test the feasibility and acceptability of increasing PA and Vitamin D supplementation interventions in older, obese people with knee osteoarthritis, with low baseline levels of PA and Vitamin D by performing a 2*2 design pilot randomized controlled trial and a qualitative interview.
The secondary aims of this project is to:
- Explore the relationships between Vitamin D levels, PA levels and KOA pain (using cross-sectional study results)
- Estimate effect sizes and inter-individual variation which can be used in the design of a future definitive RCT.
The project refers to 2 integrated studies:
- Firstly a cross-sectional study to identify individuals with low vitamin D concentrations, low Physical activity levels, who are obese and who meet the ACR KOA criteria for knee osteoarthritis.
- Secondly a pilot randomized controlled trial, which aims to test the feasibility and acceptability of administering vitamin D or placebo capsules and increasing physical activity over a 3 month period.
These 2 studies will run consecutively over 2 winter periods or phases: phase 1 (November 2014- January 2015: cross sectional study followed by intervention study (February 2015- May 2015). Phase 2 will run over the same time periods 1 year later.
- Cross-sectional study potential participant identification (November 2014-January 2015): On Tyneside, the investigators will identify potential participants by screening GP surgery patient lists against inclusion criteria (see A17-1). At the Liverpool site, participants will be identified by research staff at hospital clinics (obesity). Potentially eligible people will be mailed/given a letter of invitation, together with information about the study and a consent form to take home and consider. Those interested in joining the study will be invited to contact their local research team using the contact information provided.
- Cross-sectional study screening(November-January 2014/15): Potential participants will complete a brief telephone screening questionnaire when they call to register their interest in the study to verify their eligibility. The CI will then call back to inform the potential participant of their eligibility and, if eligible, an appointment will be made to attend for the cross-sectional study visit (study visit 1).
- Cross-sectional study visit: study visit 1 (November-January 2014/15): Participants will attend an appointment at North Tyneside General Hospital or Aintree Hospital Liverpool (depending on their research site) lasting 1 hour 30 minutes. The visit will begin by reviewing the participant information sheet and completing the consent form. After this, several measurements will be completed:
- Blood samples
- Questionnaires
- Body composition At the end of the study visit, the participants will be given a accelerometer to wear for the next 3 days. Participants will be provided with instructions on accelerometer use, activity log and a prepaid envelope in which to return the device.
- Screening for eligibility for pilot RCT (January 2015): Using data from the cross-sectional study, participants with low vitamin D concentration (25-50nmol/L) and low physical activity levels (<30min/week moderate activity)will be invited to participate in the pilot RCT.
- Pilot RCT starter session (study visit 2) (February 2015/16): Participants will attend a starter session for the pilot RCT study at North Tyneside General Hospital or Aintree hospital Liverpool. Prior to their appointment, all participants will be randomly allocated (stratified by gender) to 1 of 4 treatment arms:
- Vitamin D supplementation: 2000IU/day vitamin D capsule
- Placebo: 1/day edible oil capsule (identical to vitamin D capsule)
- Physical activity intervention (online system to record daily step using a pedometer provided, which slowly increase step and physical activity goals)
- Vitamin D + Physical activity intervention. The investigator will explain how to undertake the intervention, provide study materials and answer any questions the participant may have. Vitamin D and Placebo intervention will be blinded to the participants.
- 6 week follow up (study visit 3)(March 2015/16: All pilot RCT participants will be invited back at 6 weeks into their intervention period for a study visit lasting 1-1hr 15 minutes, at either NTGH or UHA. The same measurements taken during the cross-sectional study visit will be taken with some additional compliance measures.
- 12 week follow up (study visit 4) (April/May 2015/16): All pilot RCT participants will be invited back at 12 weeks into their intervention period for a study visit lasting 1-1hr 15 minutes at NTGH or UHA. This will be the study close for those not taking part in the qualitative interview. The same measurements will be taken as in study visit 3. Participants will be mailed feedback on their study measures including vitamin D status.
- Qualitative interview (April/May 2015/16):
A subset of up to 20 participants will be invited to take part in a qualitative interview at NTGH or UHA directly after study visit 4. The interview will last 1hr and explore participants views in a range of topics which may identify areas of improvement in the design, delivery or practical arrangements of the studies in order to inform future studies in this area.
- Conditions
- Knee Osteoarthritis
- Being tested
- Vitamin D3 2000IU/daily 3 months, PA intervention People with Osteoarthritis Walking Programme, Placebo capsule (Vitamin D): edible oil
- Keywords
- Knee osteoarthritis, Pain, Vitamin D, Physical activity, Pilot study, Qualitative Interview, Obesity, Older adults
- Medical subject headings
- Osteoarthritis, Knee, Pain, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 2000IU/daily 3 monthsDietary supplement
Vitamin D will be provided in the form of a daily capsule over 3 months containing 2000IU of Vitamin D3 suspended in oil (manufactured and provided by DSM) with the aim of raising 25OHD levels to sufficiency (>50nmol/L) by 3 months.
PA intervention People with Osteoarthritis Walking ProgrammeBehavioural
The PA intervention will aim to increase levels of PA safely in our defined population. Participant are given a pedometer at the start of the intervention and encouraged to record their daily step counts and set step goals using the online system provided (POW: People with osteoarthritis walking programme).
Placebo capsule (Vitamin D): edible oilOther
Placebo capsules will be administered over 3 months, as daily capsules (identical to Vitamin D capsules) containing edible oil (manufactured and provided by DSM)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Vitamin D3 2000IU/daily 3 months Receives: Dietary Supplement: Vitamin D3 2000IU/daily 3 months |
| Physical Activity | Experimental | PA intervention People with Osteoarthritis Walking Programme Receives: Behavioral: PA intervention People with Osteoarthritis Walking Programme |
| Vitamin D and Physical Activity | Experimental | Vitamin D3 2000IU/daily 3 months PA intervention People with Osteoarthritis Walking Programme Receives: Dietary Supplement: Vitamin D3 2000IU/daily 3 months; Behavioral: PA intervention People with Osteoarthritis Walking Programme |
| Placebo | Placebo comparator | Placebo capsule: edible oil Receives: Other: Placebo capsule (Vitamin D): edible oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of intervention by qualitative interview
Qualitative interview with n=20 after last pilot RCT study visit. Interviews will be audio recorded, transcribed and analyzed using a thematic approach using NVivo software to identify main issues.
Measured: 1 hour
Secondary outcomes (10)
Self reported knee joint pain and function by WOMAC Questionnaire
Questionnaire designed to measure osteoarthritic pain specifically, administered at cross sectional and follow up pilot RCT study visits.
Measured: 15 mins
Objectively measured (by accelerometer) physical activity
PA will be measured after cross-sectional study visit and pilot RCT follow up visits.
Measured: 3 days
Serum vitamin D concentrations measured by venous blood sample
Venous blood samples taken at cross-sectional study visit and pilot RCT follow up visits, processed and serum sent to DSM for analysis.
Measured: 10 mins
Serum vitamin D concentrations measured by Dried Blood Spot sample
Dried blood spot samples taken at cross-sectional study visit and pilot RCT follow up visits, processed and DBS cards sent to DSM for analysis.
Measured: 10 mins
Serum Calcium concentrations measured by venous blood sample
Venous blood samples taken at cross-sectional study visit and pilot RCT follow up visits, processed and brought to Freeman Hospital Laboratory for analysis.
Measured: 10 mins
Musculoskeletal function measured by Timed up and go test
Timed up and go test performed at cross-sectional study visit and pilot RCT follow up visits
Measured: 15 mins
Body composition measured by Tanita scales
Weight, BMI and body Fat % measured using Tanita Bio impedance scales at cross-sectional study visit and pilot RCT follow up visits
Measured: 10 mins
Height measured by stadiometer
Height in cm measured using stadiometer at cross-sectional study visit and pilot RCT follow up visits
Measured: 5 mins
Waist circumference measured using tape measure
Waist circumference measured in cm at cross-sectional study visit and pilot RCT follow up visits
Measured: 5 mins
Quality of life measured using SF-36 Questionnaire
Questionnaire specifically designed to measure physical and metal quality of life will be completed by participant at cross-sectional study visit and pilot RCT follow up visits
Measured: 10-15 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Rebecca J Brown, MSc, Study chair, Newcastle UniversityJohn C Mathers, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293889
- Sponsor's protocol ID
- NO 188
- Status last verified
- Aug 2016
- First submitted
- 13 Nov 2014
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical Activity and Vitamin D on Osteoarthritic Knee Pain in Older Obese People
- ClinicalTrials.gov ID
- NCT02293889
- Acronym / sponsor ID
- NO 188
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Pain, Vitamin D, Physical activity, Pilot study, Qualitative Interview, Obesity, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Nov 2014 (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.
Knee Osteoarthritis (KOA) is a major cause of pain and disability, particularly in those of increasing age and body fat. As there are no very effective therapies for KOA, disease often progresses until knee replacement surgery is needed. It has been observed Vitamin D and Physical Activity (PA) levels are lower in those with KOA, increased age and body fat. As the relationship between KOA, Vitamin D and PA levels are not clearly understood, this study aims to explore these relationships and the acceptability/feasibility of PA and Vitamin D interventions in those who would likely to benefit from these interventions.
200-300 people, 50-70 years, BMI 30-40kg/m2, meeting American College of Rheumatology (ACR) KOA Guidelines, will be recruited from North Tyneside and Liverpool Hospital trusts November 2014-January 2016 to participate in a single cross-sectional study visit, which will measure: Vitamin D/Calcium serum levels, BMI/Body Fat, mobility, Quality of life and pain (by questionnaire), and PA levels.
Those participants with insufficient Vitamin D levels (25-50nmol/L) and PA levels (<30min moderate PA/week), will be invited to take part in a 3 month pilot RCT study.
>64 people will be recruited for the pilot RCT and equally randomly allocated to 1 of 4 intervention groups: Vitamin D (1 capsule a day: 2000IU), Placebo (identical capsule: 1 a day), PA (online PA programme) and PA and Vitamin D. Additionally at the end of the 12 week study visit, up to 20 participants will be invited to take part in a qualitative interview exploring their experience during the two studies.
Detailed description
The primary aim of this project is to test the feasibility and acceptability of increasing PA and Vitamin D supplementation interventions in older, obese people with knee osteoarthritis, with low baseline levels of PA and Vitamin D by performing a 2*2 design pilot randomized controlled trial and a qualitative interview.
The secondary aims of this project is to:
- Explore the relationships between Vitamin D levels, PA levels and KOA pain (using cross-sectional study results)
- Estimate effect sizes and inter-individual variation which can be used in the design of a future definitive RCT.
The project refers to 2 integrated studies:
- Firstly a cross-sectional study to identify individuals with low vitamin D concentrations, low Physical activity levels, who are obese and who meet the ACR KOA criteria for knee osteoarthritis.
- Secondly a pilot randomized controlled trial, which aims to test the feasibility and acceptability of administering vitamin D or placebo capsules and increasing physical activity over a 3 month period.
These 2 studies will run consecutively over 2 winter periods or phases: phase 1 (November 2014- January 2015: cross sectional study followed by intervention study (February 2015- May 2015). Phase 2 will run over the same time periods 1 year later.
- Cross-sectional study potential participant identification (November 2014-January 2015): On Tyneside, the investigators will identify potential participants by screening GP surgery patient lists against inclusion criteria (see A17-1). At the Liverpool site, participants will be identified by research staff at hospital clinics (obesity). Potentially eligible people will be mailed/given a letter of invitation, together with information about the study and a consent form to take home and consider. Those interested in joining the study will be invited to contact their local research team using the contact information provided.
- Cross-sectional study screening(November-January 2014/15): Potential participants will complete a brief telephone screening questionnaire when they call to register their interest in the study to verify their eligibility. The CI will then call back to inform the potential participant of their eligibility and, if eligible, an appointment will be made to attend for the cross-sectional study visit (study visit 1).
- Cross-sectional study visit: study visit 1 (November-January 2014/15): Participants will attend an appointment at North Tyneside General Hospital or Aintree Hospital Liverpool (depending on their research site) lasting 1 hour 30 minutes. The visit will begin by reviewing the participant information sheet and completing the consent form. After this, several measurements will be completed:
- Blood samples
- Questionnaires
- Body composition At the end of the study visit, the participants will be given a accelerometer to wear for the next 3 days. Participants will be provided with instructions on accelerometer use, activity log and a prepaid envelope in which to return the device.
- Screening for eligibility for pilot RCT (January 2015): Using data from the cross-sectional study, participants with low vitamin D concentration (25-50nmol/L) and low physical activity levels (<30min/week moderate activity)will be invited to participate in the pilot RCT.
- Pilot RCT starter session (study visit 2) (February 2015/16): Participants will attend a starter session for the pilot RCT study at North Tyneside General Hospital or Aintree hospital Liverpool. Prior to their appointment, all participants will be randomly allocated (stratified by gender) to 1 of 4 treatment arms:
- Vitamin D supplementation: 2000IU/day vitamin D capsule
- Placebo: 1/day edible oil capsule (identical to vitamin D capsule)
- Physical activity intervention (online system to record daily step using a pedometer provided, which slowly increase step and physical activity goals)
- Vitamin D + Physical activity intervention. The investigator will explain how to undertake the intervention, provide study materials and answer any questions the participant may have. Vitamin D and Placebo intervention will be blinded to the participants.
- 6 week follow up (study visit 3)(March 2015/16: All pilot RCT participants will be invited back at 6 weeks into their intervention period for a study visit lasting 1-1hr 15 minutes, at either NTGH or UHA. The same measurements taken during the cross-sectional study visit will be taken with some additional compliance measures.
- 12 week follow up (study visit 4) (April/May 2015/16): All pilot RCT participants will be invited back at 12 weeks into their intervention period for a study visit lasting 1-1hr 15 minutes at NTGH or UHA. This will be the study close for those not taking part in the qualitative interview. The same measurements will be taken as in study visit 3. Participants will be mailed feedback on their study measures including vitamin D status.
- Qualitative interview (April/May 2015/16):
A subset of up to 20 participants will be invited to take part in a qualitative interview at NTGH or UHA directly after study visit 4. The interview will last 1hr and explore participants views in a range of topics which may identify areas of improvement in the design, delivery or practical arrangements of the studies in order to inform future studies in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin D3 2000IU/daily 3 monthsVitamin D3 2000IU/daily 3 months |
| Physical Activity | Experimental | Behavioral: PA intervention People with Osteoarthritis Walking ProgrammePA intervention People with Osteoarthritis Walking Programme |
| Vitamin D and Physical Activity | Experimental | Dietary Supplement: Vitamin D3 2000IU/daily 3 months, Behavioral: PA intervention People with Osteoarthritis Walking ProgrammeVitamin D3 2000IU/daily 3 months PA intervention People with Osteoarthritis Walking Programme |
| Placebo | Placebo comparator | Other: Placebo capsule (Vitamin D): edible oilPlacebo capsule: edible oil |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- CROSS SECTIONAL STUDY
- Obese: BMI 30-40kg/m2 as defined by WHO criteria
- Older adults: 50 - 70 years
- OA of the knee according to ACR Guidelines on symptomatic Knee OA criteria (using history and physical examination:
- Good understanding of written and spoken English (as no translation services will be available to this study).
Key exclusion criteria (32 listed)
- CROSS-SECTIONAL STUDY
- Any other type of arthritic condition, e.g. RA, Fibromyalgia, Ankylosing Spondylitis, Gout, Lupus, Paget's Disease, Polymyalgia rheumatic (PMR), Psoriatic arthritis, Scleroderma, Sjogrens Syndrome
- Currently taking part in a PA/exercise regime
- Taking Vitamin D, cod liver oil or Calcium capsules/supplements (topical/oral/intravenous, prescribed/non-prescribed) above 10µg/day of vitamin D and/or 500µg/day of calcium.
- Taking part in another intervention/trial (depending on researchers discretion)
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 |
|---|---|---|
| Vitamin D3 2000IU/daily 3 monthsVitamin D will be provided in the form of a daily capsule over 3 months containing 2000IU of Vitamin D3 suspended in oil (manufactured and provided by DSM) with the aim of raising 25OHD levels to sufficiency (>50nmol/L) by 3 months. | Dietary supplement | Vitamin D, Vitamin D and Physical Activity |
| PA intervention People with Osteoarthritis Walking ProgrammeThe PA intervention will aim to increase levels of PA safely in our defined population. Participant are given a pedometer at the start of the intervention and encouraged to record their daily step counts and set step goals using the online system provided (POW: People with osteoarthritis walking programme). | Behavioural | Physical Activity, Vitamin D and Physical Activity |
| Placebo capsule (Vitamin D): edible oilPlacebo capsules will be administered over 3 months, as daily capsules (identical to Vitamin D capsules) containing edible oil (manufactured and provided by DSM) | Other | Placebo |
Primary outcome
Feasibility and acceptability of intervention by qualitative interview
Time frame: 1 hour
Qualitative interview with n=20 after last pilot RCT study visit. Interviews will be audio recorded, transcribed and analyzed using a thematic approach using NVivo software to identify main issues.
10 secondary outcomes
Self reported knee joint pain and function by WOMAC Questionnaire
Time frame: 15 mins
Objectively measured (by accelerometer) physical activity
Time frame: 3 days
Serum vitamin D concentrations measured by venous blood sample
Time frame: 10 mins
Serum vitamin D concentrations measured by Dried Blood Spot sample
Time frame: 10 mins
Serum Calcium concentrations measured by venous blood sample
Time frame: 10 mins
Musculoskeletal function measured by Timed up and go test
Time frame: 15 mins
Body composition measured by Tanita scales
Time frame: 10 mins
Height measured by stadiometer
Time frame: 5 mins
Waist circumference measured using tape measure
Time frame: 5 mins
Quality of life measured using SF-36 Questionnaire
Time frame: 10-15 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 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.
Rebecca J Brown, MSc study chair
Newcastle University
John C Mathers, PhD principal investigator
Newcastle University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 2000IU/daily 3 months and PA intervention People with Osteoarthritis Walking Programme in people with Knee Osteoarthritis, run by Newcastle University at 2 sites 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 19 inclusion and 32 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: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility and acceptability of intervention by qualitative interview (time frame: 1 hour). 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 4 Aug 2016.