Primary dysmenorrhea. Primary dysmenorrhoea
Conditions
Interventions
Intervention 1: Intervention group I: Subjects will take one combined tablet containing calcium (1000 mg) and vitamin D (5000 IU) daily from about 2 weeks before starting bleeding flow until dysmenorr
Treatment - Drugs
Placebo
Intervention group I: Subjects will take one combined tablet containing calcium (1000 mg) and vitamin D (5000 IU) daily from about 2 weeks before starting bleeding flow until dysmenorrhea pain relief
Intervention group II: Subjects will take one tablet containing 1000 mg calcium daily from about 2 weeks before starting bleeding flow until dysmenorrhea pain relief in the next cycle (about 18 tablet
Intervention group III: Subjects will take a placebo tablet daily from about 2 weeks before starting bleeding flow until dysmenorrhea pain relief in the next cycle (about 18 tablets a cycle) for three
Sponsors
Research deputy of Tabriz university of medical sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSomaye Zarei
Midwifery Department, Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Outcome results
None listed