Hypovitaminosis D
Conditions
Brief summary
The purpose of this study is to evaluate the effect of vitamin D supplementation on the pain score of primary dysmenorrhea. Our hypothesis is that by normalizing vitamin D level could help improve pain score of women who have primary dysmenorrhea.
Detailed description
This study is aimed to be conducted in randomised controlled trial, comparing between intervention group and placebo group. We include women with primary dysmenorrhea who also have low vitamin D level in this trial. Our primary outcome is to compare visual analog pain scale between intervention and placebo group after treatment. After randomised and allocated, these women will be given vitamin D 50,000 IU or placebo capsules orally weekly for 8 consecutive weeks. We monitor pain score daily from the cycle before the drugs started until complete 8-week course of the regimen mentioned. Also vitamin D levels will be monitored twice, one before treatment and the other after treatment.
Interventions
Given to subjects 50,000 IU per week for 8 weeks
DRUGPlacebo
Placebo capsules
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomised controlled study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Primary dysmenorrhea * Hypovitaminosis D
Exclusion criteria
* Using calcium, magnesium or phosphorus in the past 3 months * Using hormonal contraception or IUD in the past 6 months * No smoking or alcohol drinking * Chronic underlying diseases * Allergic to components in study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog pain scale | 8 weeks | Pain score between intervention and placebo group after treatment |
Contacts
Primary ContactMananya Silpakit, Doctor
Outcome results
None listed