Effectiveness of Vitamin D in Primary Dysmenorrhoea

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

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

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhoea
• Intervention / Treatment: Dietary supplement: Vitamin D; Drug: Ibuprofen; Dietary supplement: Vitamin E

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Vitamin D; Other Names: Devit-3 damla barcod number 8699525590435 ,DEVA Holding AŞ
Experimental: 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.	Dietary supplement: Vitamin E; Other Names: Evicap d-alfa-Tokoferol, KOÇAK Farma
Experimental: ibuprofen; 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; Other Names: profen Dinçtaş İlaç

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Collaborators: Seda Ates; Osman Sevket; Mucize Ozdemir; Gulsah Ilhan; Yildirim, Zeynep Baysal, M.D.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 11, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: vitamin D
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Protective Agents; Micronutrients; Bone Density Conservation Agents; Antioxidants; Vitamin D; Vitamin E; Vitamins; Ibuprofen
• Other Study ID Numbers: BezmialemVU