Effectiveness of Vitamin D in Primary Dysmenorrhoea

NCT02441530 | Completed Phase 3

• 1 other identifier: BezmialemVU
• Study Type: interventional
• Target: 143
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Primary Dysmenorrhoea

Keywords

vitamin D

Outcome Measures

Primary Outcomes (1)

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

  2 months

Study Arms (3)

vitamin D

EXPERIMENTAL

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

vitamin E

EXPERIMENTAL

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

ibuprofen

EXPERIMENTAL

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

Interventions

Vitamin D DIETARY_SUPPLEMENT

Also known as: Devit-3 damla barcod number 8699525590435 ,DEVA Holding AŞ

vitamin D

Vitamin E DIETARY_SUPPLEMENT

Also known as: Evicap d-alfa-Tokoferol, KOÇAK Farma

vitamin E

Ibuprofen DRUG

Also known as: profen Dinçtaş İlaç

ibuprofen

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Interventions

Vitamin D; Vitamin E; Ibuprofen

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 12, 2015
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 12, 2015

Record last verified: 2015-05