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

Primary Purpose

Hypovitaminosis D

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ergocalciferol Capsules
Placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypovitaminosis D

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vitamin D

    Placebo

    Arm Description

    Vitamin D 50,000 IU orally weekly for 8 weeks

    Placebo capsules orally weekly for 8 weeks

    Outcomes

    Primary Outcome Measures

    Visual analog pain scale
    Pain score between intervention and placebo group after treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    March 31, 2021
    Last Updated
    March 31, 2021
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04829487
    Brief Title
    The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2021 (Anticipated)
    Primary Completion Date
    April 30, 2023 (Anticipated)
    Study Completion Date
    April 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypovitaminosis D

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomised controlled study
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin D
    Arm Type
    Experimental
    Arm Description
    Vitamin D 50,000 IU orally weekly for 8 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo capsules orally weekly for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ergocalciferol Capsules
    Other Intervention Name(s)
    Vitamin D2
    Intervention Description
    Given to subjects 50,000 IU per week for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo capsules
    Primary Outcome Measure Information:
    Title
    Visual analog pain scale
    Description
    Pain score between intervention and placebo group after treatment
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mananya Silpakit, Doctor
    Phone
    +66987795945
    Email
    msilpakit@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mananya Silpakit, Doctor
    Organizational Affiliation
    Reproductive medicine unit, Department of OB-GYN, Faculty of Medicine, Siriraj Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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