Effectiveness of Vitamin D in Primary Dysmenorrhoea

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Dysmenorrhoea

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Vitamin E
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D<br>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. | Dietary Supplement: Vitamin D<br> <br> * Other names: Devit-3 damla barcod number 8699525590435 ,DEVA Holding AŞ;|
| Experimental: vitamin E<br>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. | Dietary Supplement: Vitamin E<br> <br> * Other names: Evicap d-alfa-Tokoferol, KOÇAK Farma;|
| Experimental: ibuprofen<br>400 mg ibuprofen twice a day, two days before the expected date of menstruation and continued through the first three days of bleeding. | Drug: Ibuprofen<br> <br> * Other names: profen Dinçtaş İlaç;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score ,make a mark on a 10-cm visual analog scale (VAS) |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D