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Completed

NCT Number: NCT02441530

Effectiveness of Vitamin D in Primary Dysmenorrhoea

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

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Key information

Age range

16 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Vitamin D

Dietary Supplement

Other names: Devit-3 damla barcod number 8699525590435 ,DEVA Holding AŞ

Vitamin E

Dietary Supplement

Other names: Evicap d-alfa-Tokoferol, KOÇAK Farma

Ibuprofen

Drug

Other names: profen Dinçtaş İlaç

Primary outcomes

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

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 12, 2015
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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