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Effectiveness of Vitamin D in Primary Dysmenorrhoea

Primary Purpose

Primary Dysmenorrhoea

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Vitamin D

Vitamin E

Ibuprofen

About this trial

This is an interventional treatment trial for Primary Dysmenorrhoea focused on measuring vitamin D

Eligibility Criteria

16 Years - 35 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

1) Previous and current use of intrauterine contraceptive devices within the 6 months to enrollment was not permitted

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

vitamin D

vitamin E

ibuprofen

Arm Description

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.

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.

400 mg ibuprofen twice a day, two days before the expected date of menstruation and continued through the first three days of bleeding.

Outcomes

Primary Outcome Measures

pain score ,make a mark on a 10-cm visual analog scale (VAS)

Secondary Outcome Measures

Full Information

NCT ID

NCT02441530

First Posted

May 8, 2015

Last Updated

May 11, 2015

Sponsor

Bezmialem Vakif University

Collaborators

Seda Ates, Osman Sevket, Mucize Ozdemir, Gulsah Ilhan, Yildirim, Zeynep Baysal, M.D.

1. Study Identification

Unique Protocol Identification Number

NCT02441530

Brief Title

Effectiveness of Vitamin D in Primary Dysmenorrhoea

Official Title

Vitamin D in the Treatment of Primary Dysmenorrhoea: A Prospective Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bezmialem Vakif University

Collaborators

Seda Ates, Osman Sevket, Mucize Ozdemir, Gulsah Ilhan, Yildirim, Zeynep Baysal, M.D.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

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

Primary Dysmenorrhoea

Keywords

vitamin D

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

143 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vitamin D

Arm Type

Experimental

Arm Description

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.

Arm Title

vitamin E

Arm Type

Experimental

Arm Description

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.

Arm Title

ibuprofen

Arm Type

Experimental

Arm Description

400 mg ibuprofen twice a day, two days before the expected date of menstruation and continued through the first three days of bleeding.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Other Intervention Name(s)

Devit-3 damla barcod number 8699525590435 ,DEVA Holding AŞ

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin E

Other Intervention Name(s)

Evicap d-alfa-Tokoferol, KOÇAK Farma

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Other Intervention Name(s)

profen Dinçtaş İlaç

Primary Outcome Measure Information:

Title

pain score ,make a mark on a 10-cm visual analog scale (VAS)

Time Frame

2 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 1) Previous and current use of intrauterine contraceptive devices within the 6 months to enrollment was not permitted

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Vitamin D in Primary Dysmenorrhoea

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