Primary DysmenorrhoeaPhase 3NCT02441530
Effectiveness of Vitamin D in Primary Dysmenorrhoea
A Phase 3 study testing Vitamin D, Vitamin E and Ibuprofen in people with Primary Dysmenorrhoea, run by Bezmialem Vakif University.
Trial summary
Vitamin D in the treatment of primary dysmenorrhoea. Design:Randomised controlled trial. Setting:In a university hospital. Population: 142 women aged 16-35 years. Methods: Patients were treated with 667 unit of vitamin D once a day, 200 unit of vitamin E once a day or 400 mg ibuprofen twice a day,2 days before the… Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhoea
- What is being tested?
- Vitamin D, Vitamin E and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women had regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 7 days;
- Women had to be in good health and taking no medications including calcium, magnesium, vitamin D and oral contraceptives.
- Women had not a previous history of gynaecological disease, and a normal pelvic examination were eligible.
Who cannot join
- 1) Previous and current use of intrauterine contraceptive devices within the 6 months to enrollment was not permitted
About this study
Official title: Vitamin D in the Treatment of Primary Dysmenorrhoea: A Prospective Randomised Controlled Trial
Vitamin D in the treatment of primary dysmenorrhoea. Design:Randomised controlled trial. Setting:In a university hospital. Population: 142 women aged 16-35 years. Methods: Patients were treated with 667 unit of vitamin D once a day, 200 unit of vitamin E once a day or 400 mg ibuprofen twice a day,2 days before the date of menstruation and continued through the first 3 days, for 2 months. Main outcome measures: Pain score. Results: Mean VAS of vitamin D group was 4,91, was 6,54 in the vitamin E group and was 4,02 in the ibuprofen group Conclusion:Vitamin D and vitamin E are effective in relieving the pain,but the effect of vitamin D are more prominent
Read the detailed description
An excessive uterine production of prostaglandins is the pathogenic trigger of dysmenorrhoea. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the currently accepted drugs for the management of this disorder. The capacity for synthesizing vitamin D and the presence of vitamin D receptor in human cycling endometrium have also been demonstrated. Because vitamin D reduces the synthesis of prostaglandins, a beneficial effect of vitamin D for the uterus is possible.Vitamin E inhibits the release of arachidonic acid and the conversion of arachidonic acid to prostaglandin via an action on the enzymes phospholipase A2 and cyclooxygenase.
- Conditions
- Primary Dysmenorrhoea
- Keywords
- vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Devit-3 damla barcod number 8699525590435 ,DEVA Holding AŞ
Vitamin EDietary supplement
Also called Evicap d-alfa-Tokoferol, KOÇAK Farma
IbuprofenDrug
Also called profen Dinçtaş İlaç
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Experimental | 667 unit of vitamin D once a day ,two days before the expected date of menstruation and continued through the first three days of bleeding. Receives: Dietary Supplement: Vitamin D |
| vitamin E | Experimental | 200 unit of vitamin E once a day ,two days before the expected date of menstruation and continued through the first three days of bleeding. Receives: Dietary Supplement: Vitamin E |
| ibuprofen | Experimental | 400 mg ibuprofen twice a day, two days before the expected date of menstruation and continued through the first three days of bleeding. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score ,make a mark on a 10-cm visual analog scale (VAS)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrhoeaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Seda Ates, Osman Sevket, Mucize Ozdemir, Gulsah Ilhan, Yildirim, Zeynep Baysal, M.D.
- Responsible party
- Principal investigator, Aysegül Özel, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441530
- Sponsor's protocol ID
- BezmialemVU
- Status last verified
- May 2015
- First submitted
- 8 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D in the Treatment of Primary Dysmenorrhoea: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02441530
- Acronym / sponsor ID
- BezmialemVU
- Conditions
- Primary Dysmenorrhoea
- Keywords
- vitamin D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Seda Ates, Osman Sevket, Mucize Ozdemir, Gulsah Ilhan, Yildirim, Zeynep Baysal, M.D.
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D in the treatment of primary dysmenorrhoea. Design:Randomised controlled trial. Setting:In a university hospital. Population: 142 women aged 16-35 years. Methods: Patients were treated with 667 unit of vitamin D once a day, 200 unit of vitamin E once a day or 400 mg ibuprofen twice a day,2 days before the date of menstruation and continued through the first 3 days, for 2 months. Main outcome measures: Pain score. Results: Mean VAS of vitamin D group was 4,91, was 6,54 in the vitamin E group and was 4,02 in the ibuprofen group Conclusion:Vitamin D and vitamin E are effective in relieving the pain,but the effect of vitamin D are more prominent
Detailed description
An excessive uterine production of prostaglandins is the pathogenic trigger of dysmenorrhoea. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the currently accepted drugs for the management of this disorder. The capacity for synthesizing vitamin D and the presence of vitamin D receptor in human cycling endometrium have also been demonstrated. Because vitamin D reduces the synthesis of prostaglandins, a beneficial effect of vitamin D for the uterus is possible.Vitamin E inhibits the release of arachidonic acid and the conversion of arachidonic acid to prostaglandin via an action on the enzymes phospholipase A2 and cyclooxygenase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Experimental | Dietary Supplement: Vitamin D667 unit of vitamin D once a day ,two days before the expected date of menstruation and continued through the first three days of bleeding. |
| vitamin E | Experimental | Dietary Supplement: Vitamin E200 unit of vitamin E once a day ,two days before the expected date of menstruation and continued through the first three days of bleeding. |
| ibuprofen | Experimental | Drug: Ibuprofen400 mg ibuprofen twice a day, two days before the expected date of menstruation and continued through the first three days of bleeding. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Women had regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 7 days;
- Women had to be in good health and taking no medications including calcium, magnesium, vitamin D and oral contraceptives.
- Women had not a previous history of gynaecological disease, and a normal pelvic examination were eligible.
Key exclusion criteria (1 listed)
- 1) Previous and current use of intrauterine contraceptive devices within the 6 months to enrollment was not permitted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Devit-3 damla barcod number 8699525590435 ,DEVA Holding AŞ | Dietary supplement | vitamin D |
| Vitamin EAlso: Evicap d-alfa-Tokoferol, KOÇAK Farma | Dietary supplement | vitamin E |
| IbuprofenAlso: profen Dinçtaş İlaç | Drug | ibuprofen |
Primary outcome
pain score ,make a mark on a 10-cm visual analog scale (VAS)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D, Vitamin E and Ibuprofen in people with Primary Dysmenorrhoea, run by Bezmialem Vakif University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score ,make a mark on a 10-cm visual analog scale (VAS) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.