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UnknownNCT04829487

The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D

The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D: A Randomized, Double-blind, Placebo-Controlled Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
36 (estimated)
Sponsor
Mahidol University · Academic / Other
Sex
Female
Age
18 Years – 30 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGErgocalciferol CapsulesGiven to subjects 50,000 IU per week for 8 weeks
DRUGPlaceboPlacebo capsules

Timeline

Start date
2021-05-01
Primary completion
2023-04-30
Completion
2023-04-30
First posted
2021-04-02
Last updated
2021-04-02

Source: ClinicalTrials.gov record NCT04829487. Inclusion in this directory is not an endorsement.