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
About this trial
This is an interventional treatment trial for Hypovitaminosis D
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
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
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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