Only first 10,000 results will be saved in the file.
No item is selected. Use checkboxes to select search results.
Displaying 1-1 of 1 results.
{{ selectedCountPage }} items selected on this page,{{ selectedCountPage }} item selected on this page,{{ selectedCountTotal }} item in total{{ selectedCountTotal }} items in total
Study aim:
To evaluate the effect of vitamin D supplementation on the severity, duration and frequency of headache attacks in adolescents with migraine.
Design:
A randomized; parallel group; double-blind (outcome assessor and statistical analyst blinded); phase 3 clinical trial of 112 patients. Randomization was performed using a permuted block method with a block size of 4 to ensure concealed allocation sequence.
Settings and conduct:
Setting: Pediatric Neurology Clinic of ValiAsr Hospital of Birjand; one hundred and twelve adolescents randomized into two groups; outcome assessor and statistical analyst are blinded.
Participants/Inclusion and exclusion criteria:
Inclusion criteria: Age twelve to eighteen years; migraine diagnosis; stable Sodium Valproate dose. Exclusion criteria: Renal disease; recent supplement use; high serum calcium.
Intervention groups:
Intervention group: Receiving routine treatment with Sodium Valproate tablets; plus weekly consumption of one Vitamin D softgel containing 50000 International Units for 10 weeks.
Control group: Receiving routine treatment with Sodium Valproate tablets only; without receiving any additional supplements or placebos.
Main outcome variables:
Mean headache intensity score; time of measurement at baseline and 10 weeks after the initiation of the intervention; measurement tool is the Visual Analog Scale from score 0 to 10.