materials and methods design open-label, randomized trial, february 2010 to may 2011, avoiding the...

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Page 1: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 2: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Materials and methods

• Design• Open-label, randomized trial, February 2010 to May 2011, avoiding the

summer period

• Participants• recruited from a primary care centre in Sweden, serving a population with a

high proportion of non-European residents

• Inclusion criteria • age 15 years or above and vitamin D deficiency 25(OH)D3 less than 25

nmol /L

• Exclusion criteria• light-sensitive skin• ongoing treatment with vitamin D supplementation• sunny holidays • intake of photosensitive medicine during the study period.

Page 3: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 4: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

UVB

• The average starting dose was 0.36 J• increments were about 15% every second treatment session• the average maximal (final) dose was 1.20 J.• The mean cumulative dose was 9.0 J /cm2

Page 5: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 6: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 7: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Results

• Significantly greater increase in 25(OH)D3 levels in the NB-UVB treated group compared with the tablet-treated group after 6 weeks of treatment (P = 0.02)

• in the NB-UVB treated group The 25(OH)D3 levels (mean ± SD) increased from 19.2 ± 6 nmol /L to 75 ± 16.8 nmol/L vs. 23.3 ±4.4 nmol /L to 60.6 ± 16.7 nmol /L in the oral vitamin D3 treated group

Page 8: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Results

• No significant difference regarding PTH, calcium, albumin or HbA1c levels.

• A significant decrease in PTH

• A significant increase in calcium levels

Page 9: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Limitations

• lack of compliance among the group who took vitamin D3 supplements

• high dropout number

• primarily non-European immigrants

Page 10: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Conclusion

• exposure to a small dose of full body NB-UVB radiation three times a week is more efficient in raising vitamin D levels than prescription of a daily oral intake of 1600 IU vitamin D3

Page 11: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Race ?Skin type?

Page 12: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 13: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 14: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Suscreen?

Page 15: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 16: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 17: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Winter vs summer

Page 18: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 19: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 20: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

NB UVB vs BB UVB?

Page 21: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 22: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Diet?

Page 23: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 24: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Screening?

Page 25: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 26: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Deficiency?

Page 27: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

-Vitamin D deficiency is defined as a 25(OH)D below 20 ng/ml (50 nmol/liter)

- Vitamin D insufficiency is defined as a 25(OH)D of 21–29 ng/ml

Page 28: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Daily requirement?

Page 29: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 30: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary
Page 31: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary

Treatment

Page 32: Materials and methods Design Open-label, randomized trial, February 2010 to May 2011, avoiding the summer period Participants recruited from a primary