Impact of Physical Activity and Vitamin D on Osteoarthritic Knee Pain

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

Interventions

DIETARY_SUPPLEMENT

Vitamin D3 2000IU/daily 3 months

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.

BEHAVIORAL

PA intervention People with Osteoarthritis Walking Programme

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).

OTHER

Placebo capsule (Vitamin D): edible oil

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

Sponsors & Collaborators

• Northumbria Healthcare NHS Foundation Trust

  collaborator OTHER

• Newcastle University

  lead OTHER

Principal Investigators

• Rebecca J Brown, MSc · Newcastle University

• John C Mathers, PhD · Newcastle University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

50 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2016-07-31

Completion

2016-07-31

Countries

• United Kingdom

Study Locations