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IRCT201402043706N21 IRCT 2014-02-22 Research deputy of Tabriz university of medical sciences Effect of combined calcium-vitamin D and only calcium on pain severity and menstrual bleeding in students with primary dysmenorrhea Effect of combined calcium-vitamin D and only calcium on pain severity and menstrual bleeding in students with primary dysmenorrhea: a randomized placebo-controlled trial 2014-02-26 anticipated 90 Complete https://irct.ir/trial/3812 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, participants will be recommended to take no pharmacological or non-pharmacological analgesic for dysmenorrhea pain relief during study period, except the Gelofen tablets (which will be given them by the investigators) and record number of the taken tablets. Stratified allocation based on amount of calcium and vitamin D intake (assessed using a food frequency questionnaire) will be used to have equal number of subjects with calcium and vitamin D deficiency in the three groups. N/A Primary dysmenorrhea. 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 dysmenorrhea pain relief in the next cycle (about 18 tablets a cycle) for three consecutive cycles. Intervention 2: 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 tablets a cycle) for three consecutive cycles. Intervention 3: 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 consecutive cycles.
public Somaye Zarei
Kousar Dormitory, South Shariati Ave, Tabriz
Tabriz Iran (Islamic Republic of) +98 21 5612 2511 zareie_somaye@yahoo.com , raha0517@yahoo.com Midwifery Department, Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh-Charandabi
Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz, Post Code: 5138947977, P.O.Box: 51745-347
Tabriz Iran (Islamic Republic of) +98 41 1477 2699 alizades@tbzmed.ac.ir; smoalch@yahoo.com Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 30 years Female N94.4 Primary dysmenorrhoea Treatment - Drugs 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 in the next cycle (about 18 tablets a cycle) for three consecutive cycles 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 tablets a cycle) for three consecutive cycles 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 consecutive cycles 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. 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. Research deputy of Tabriz university of medical sciences Approved 2013-12-02 Ethics Committee in Tabriz University of Medical Sciences 3rd floor, Centeral building No 2, Tabriz University of Medical Sciences, Golgasht st. Tabriz Iran (Islamic Republic of)