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Table 1 Timetable and measures to be made

From: Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial

 

Screening

Month(s)

  

0

3

6

12

24

Co-primary outcome measure

MRI (cartilage volume changes)

 

✓

   

✓

WOMAC

 

✓

✓

✓

✓

✓

Secondary outcome measure

      

MRI (other structural changes)

 

✓

   

✓

Lower limb muscle strength

 

✓

✓

✓

✓

✓

Other measures

Core musculature measure

 

✓

  

✓

✓

Hand grip strength

 

✓

✓

✓

✓

✓

Central and upper arm blood pressure

 

✓

 

✓

✓

✓

Aortic stiffness

 

✓

 

✓

✓

✓

Physical activity (IPAQ)

 

✓

   

✓

Body fat

 

✓

  

✓

✓

Low foot pain

 

✓

✓

✓

✓

✓

Low back pain

 

✓

 

✓

✓

✓

Depression

 

✓

✓

✓

✓

✓

Quality of life

 

✓

 

✓

✓

✓

Previous knee injury and occupation

 

✓

   

✓

Weight

 

✓

✓

✓

✓

✓

Height

 

✓

   

✓

Girth measurements

 

✓

  

✓

✓

Knee radiograph

✓

     

Serum 25-(OH)D

✓

 

✓

  

✓

Serum calcium, phosphate, creatinine

✓

 

✓

   

Sun exposure

 

✓

 

✓

✓

✓

Cigarette smoking

 

✓

   

✓

Diet (FFQ) and pedometer

 

✓

   

✓

Medications

✓

✓

✓

✓

✓

✓

Pill counts and adverse events

 

✓

✓

✓

✓

✓

  1. Participants who withdraw within one year will be asked to have MRI at month 12; patients who withdraw after one year will be asked to have MRI straight away. MRI: magnetic resonance imaging; WOMAC: Western Ontario McMaster Universities Osteoarthritis Index; 25-(OHD)D: 25-hydroxy-vitamin D; FFQ: food frequency questionnaire.