Effectiveness of Vitamin D in Primary Dysmenorrhoea

Primary Dysmenorrhoea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441530
• Other study ID #: BezmialemVU
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2015
• Last updated: May 11, 2015
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: May 2015
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: October 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhoea

Intervention

Dietary Supplement:
• Vitamin D

• Vitamin E

Drug:
• Ibuprofen

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Bezmialem Vakif University	Gulsah Ilhan, Mucize Ozdemir, Osman Sevket, Seda Ates, Yildirim, Zeynep Baysal, M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score ,make a mark on a 10-cm visual analog scale (VAS)		2 months	Yes