The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2021
CompletedFirst Posted
Study publicly available on registry
April 2, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedApril 2, 2021
March 1, 2021
2 years
March 31, 2021
March 31, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Visual analog pain scale
Pain score between intervention and placebo group after treatment
8 weeks
Study Arms (2)
Vitamin D
EXPERIMENTALVitamin D 50,000 IU orally weekly for 8 weeks
Placebo
PLACEBO COMPARATORPlacebo capsules orally weekly for 8 weeks
Interventions
Given to subjects 50,000 IU per week for 8 weeks
Eligibility Criteria
You may qualify if:
- Primary dysmenorrhea
- Hypovitaminosis D
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mananya Silpakit, Doctor
Reproductive medicine unit, Department of OB-GYN, Faculty of Medicine, Siriraj Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
March 31, 2021
First Posted
April 2, 2021
Study Start
May 1, 2021
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
April 2, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share