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NCT04829487 Clinical Trial

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

Hypovitaminosis D Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04829487
Other study ID # 247/2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date April 30, 2023

Study information
Verified date March 2021
Source Mahidol University
Contact Mananya Silpakit, Doctor
Phone +66987795945
Email msilpakit@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 36
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ergocalciferol Capsules
Given to subjects 50,000 IU per week for 8 weeks
• Placebo
Placebo capsules

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Outcome
Type Measure Description Time frame Safety issue
Primary Visual analog pain scale Pain score between intervention and placebo group after treatment 8 weeks
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