Effectiveness of Vitamin D in Primary Dysmenorrhoea

Bezmialem Vakif University

Status and phase: Completed; Phase 3

Conditions: Primary Dysmenorrhoea

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: Vitamin E; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02441530

BezmialemVU

Details and patient eligibility

About

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

Full 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.

Enrollment: 143 patients

Sex: Female

Ages: 16 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 3 patient groups

vitamin D

Experimental group

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.

Treatment:

Dietary Supplement: Vitamin D

vitamin E

Experimental group

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.

Treatment:

Dietary Supplement: Vitamin E

ibuprofen

Experimental group

Description:

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

Treatment:

Drug: Ibuprofen