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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-04-30

Brief Summary

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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.

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Detailed Description

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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

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Hypovitaminosis D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

Vitamin D 50,000 IU orally weekly for 8 weeks

Group Type EXPERIMENTAL

Ergocalciferol Capsules

Intervention Type DRUG

Given to subjects 50,000 IU per week for 8 weeks

Placebo

Placebo capsules orally weekly for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules

Interventions

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Ergocalciferol Capsules

Given to subjects 50,000 IU per week for 8 weeks

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type DRUG

Other Intervention Names

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Vitamin D2

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes