Effect of combined calcium-vitamin D and only calcium on pain severity and menstrual bleeding in students with primary dysmenorrhea

Not Applicable

• Conditions: Primary dysmenorrhea.; Primary dysmenorrhoea

• Registration Number: IRCT201402043706N21
• Lead Sponsor: Research deputy of Tabriz university of medical sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• painful and regular (35-21 days cycles) menstrual cycles during previous 3 months with maximum pain severity score of 5.0 to 9.1 assessed by VAS (0-10).
• Having pain with features of primary dysmenorrhea (constant lower abdominal pain, radiating to the back or the anterior or medial thigh, starting several hours before or just after the menstrual flow).
• No Known chronic disease (including epilepsy, gastrointestinal, cardio-vascular or renal diseases).
• Being single.
Exclusion criteria:
• No access to a phone line (for follow-up).
• Occurrence of any type of genital diseases or abdominal or pelvic surgery in the last 6 months.
• Experiencing any severe psychological stress, such as parental divorce, death of first degree relatives, etc. in the last 6 months.
• Experiencing heavy vaginal bleeding (using a pad every hour for at least 6 hours) or continuous spotting between menstrual periods is in the last 6 months.
• Having allergy to non-steroidal anti-inflammatory drugs.
• Frequent and regular intake of supplements (including calcium, vitamin D, zinc, iron) in the last 3 months.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of Menstrual pain. Timepoint: 1) one cycle before treatment 2) the first, second and third cycles under treatment 3) first cycle after treatment. Method of measurement: VAS.;Amount of menstrual bleeding. Timepoint: 1) one cycle before treatment 2) first, second and third cycles under treatment 3) first cycle after treatment. Method of measurement: Hygam chart.

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of life. Timepoint: 1) One cycle before treatment 2) the third cycle of the treament. Method of measurement: SF36 Health-related quality of life questionnaire.;Number of consumed analgesics tablets. Timepoint: 1) one cycle before treatment 2) 1,2,3 cycle during treatment 3) 1 cycle after treatment. Method of measurement: Daily recording in questionnaire.;Satisfaction with treatment. Timepoint: 1) one cycle before treatment 2) three cycle under treatment 3) one cycle after treatment. Method of measurement: Self-report.;Side events. Timepoint: 1) one cycle before treatment 2) three cycle during treatment 3) one cycle after treatment. Method of measurement: Self-report.