Effectiveness of Vitamin D in Primary Dysmenorrhoea

NCT ID: NCT02441530

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-10-31

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.

Conditions

Primary Dysmenorrhoea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vitamin D

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

vitamin E

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.

Group Type: EXPERIMENTAL

Vitamin E

Intervention Type: DIETARY_SUPPLEMENT

ibuprofen

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

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

Interventions

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Vitamin E

Intervention Type: DIETARY_SUPPLEMENT

Ibuprofen

Intervention Type: DRUG

Other Intervention Names

Devit-3 damla barcod number 8699525590435 ,DEVA Holding AŞ; Evicap d-alfa-Tokoferol, KOÇAK Farma; profen Dinçtaş İlaç

Eligibility Criteria

Inclusion Criteria

1. Women had regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 7 days;

2. Women had to be in good health and taking no medications including calcium, magnesium, vitamin D and oral contraceptives.

3. 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seda Ates

UNKNOWN

Sponsor Role: collaborator

Osman Sevket

UNKNOWN

Sponsor Role: collaborator

Mucize Ozdemir

UNKNOWN

Sponsor Role: collaborator

Gulsah Ilhan

UNKNOWN

Sponsor Role: collaborator

Yildirim, Zeynep Baysal, M.D.

INDIV

Sponsor Role: collaborator

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Aysegül Özel

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

BezmialemVU

Identifier Type: -

Identifier Source: org_study_id