Table 2 Clinical and Laboratory results a
Study group | Low dose group | High dose group | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
800 IU/day | 4370 IU/day | |||||||||
Parameter | Baseline | 3Months | 6 Months | End | p-value | Baseline | 3Months | 6 Months | End | p-value |
Annual Relapse rate | 0.38±0.26 | -- | -- | 0.34±0.27 | 0.88 b | 0.28±0.23 | -- | -- | 0.51±0.34 | 0.32 b |
EDSS | 3.6±2.2 | -- | 3.6±2.1 | 3.6±2.3 | 0.1c | 2.9±2.0 | -- | 3.4±2.3 | 3.3±2.4 | 0.26 c |
4.5 | 2.8 | 3.0 | 2.5 | 3 | 2.5 | |||||
(0-7) | (0-7) | (0-7) | (0-7) | (0-7) | (0-7) | |||||
Quality of life score (FAMS) | 145.6±30.8 | -- | -- | 142.7±32.5 | 0.68 d | 147.9±38.6 | -- | -- | 146.6±45.5 | 0.84 d |
138 | 134 | 158 | 150 | |||||||
(103-205) | (94-212) | (85-211) | (71-225) | |||||||
Serum calcium (mg/dl) | 9.5±0.4 | 9.7±0.3 | 9.5±0.4 | 9.5±0.5 | 0.4 c | 9.6±0.3 | 9.7±0.2 | 9.6±0.2 | 9.4±0.5 | 0.2 c |
9.5 | 9.6 | 9.5 | 9.4 | 9.5 | 9.5 | 9.6 | 9.4 | |||
(8.7-10.2) | (9.2-10.2) | (9-10.3) | (8.9-10.3) | (9.2-10.1) | (9.4-10.1) | (9.2-10.1) | (8.6-10.1) | |||
PTH (pg/ml) | 36.7 ±17.1 | 31.6±11.5 | -- | -- | 0.17 d | 30.4±13.5 | 25.0±10.0 | -- | -- | 0.04 d |
35.5 | 29.4 | 31.1 | 21.7 | |||||||
(11.5-77.4) | (12.8-53.3) | (8.3-49.9) | (6.4-41.4) | |||||||
IFN-γ (pg/ml) | 0.20±0.22 | 0.14±0.2 | -- | -- | 0.13 d | 0.51±1.1 | 0.58±1.3 | -- | -- | 0.7 d |
0.08 | 0.03 | 0.05 | 0.07 | |||||||
(0-0.61) | (0-0.77) | (0-4.4) | (0-5.8) | |||||||
IL17 (pg/ml) | 4.01±3.99 | 9.14±9.9 | -- | -- | 0.04 d | 5.83±6.1 | 6.38±6.7 | -- | -- | 0.75 d |
3.74 | 7.8 | 4.3 | 3.4 | |||||||
(0-11) | (0-38.3) | (0-19) | (0-20.8) | |||||||
IL10 (pg/ml) | undetected | undetected | -- | -- | -- | undetected | undetected | -- | -- | -- |