Impact of Physical Activity and Vitamin D on Osteoarthritic Knee Pain

NCT02293889 | Completed

• 1 other identifier: NO 188
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Pain; Vitamin D; Physical activity; Pilot study; Qualitative Interview; Obesity; Older adults

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour

Secondary Outcomes (10)

• Self reported knee joint pain and function by WOMAC Questionnaire

  15 mins

• Objectively measured (by accelerometer) physical activity

  3 days

• Serum vitamin D concentrations measured by venous blood sample

  10 mins

• Serum vitamin D concentrations measured by Dried Blood Spot sample

  10 mins

• Serum Calcium concentrations measured by venous blood sample

  10 mins

Study Arms (4)

Vitamin D

EXPERIMENTAL

Vitamin D3 2000IU/daily 3 months

Dietary Supplement: Vitamin D3 2000IU/daily 3 months

Physical Activity

EXPERIMENTAL

PA intervention People with Osteoarthritis Walking Programme

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

Dietary Supplement: Vitamin D3 2000IU/daily 3 months; Behavioral: PA intervention People with Osteoarthritis Walking Programme

Placebo

PLACEBO COMPARATOR

Placebo capsule: edible oil

Other: Placebo capsule (Vitamin D): edible oil

Interventions

Vitamin D3 2000IU/daily 3 months DIETARY_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.

Vitamin D; Vitamin D and Physical Activity

PA intervention People with Osteoarthritis Walking Programme BEHAVIORAL

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).

Physical Activity; Vitamin D and Physical Activity

Placebo capsule (Vitamin D): edible oil OTHER

Placebo capsules will be administered over 3 months, as daily capsules (identical to Vitamin D capsules) containing edible oil (manufactured and provided by DSM)

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Low objectively measured levels of Vitamin D, defined as:

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• Newcastle University: lead
• Northumbria Healthcare NHS Foundation Trust: collaborator

Study Sites (2)

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Location

North Tyneside General Hospital

Newcastle upon Tyne, NE29 8NH, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Motor Activity; Obesity

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Rebecca J Brown, MSc

  Newcastle University

  STUDY CHAIR

• John C Mathers, PhD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 19, 2014
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

GB (2)