Status:
COMPLETED
Impact of Physical Activity and Vitamin D on Osteoarthritic Knee Pain
Lead Sponsor:
Newcastle University
Collaborating Sponsors:
Northumbria Healthcare NHS Foundation Trust
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief 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 unti...
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 base...
Eligibility Criteria
Inclusion
- 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:
- 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 (2\*credit 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02293889
Start Date
March 1 2015
End Date
July 1 2016
Last Update
August 4 2016
Active Locations (2)
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1
Aintree University Hospital
Liverpool, United Kingdom, L9 7AL
2
North Tyneside General Hospital
Newcastle upon Tyne, United Kingdom, NE29 8NH