Protocol summary

Summary
The aim of this randomized controlled trial is to determine effectiveness of only calcium and calcium with magnesium on the pain severity and resting length of students with primary dysmenorrhoea. 80 female eligible students with medium to severe primary dysmenorrhoea (VAS≥5) will be recruited at dormitories of Aras branch of Tabriz University of Medical Sciences, after getting written informed consent. The participants will fill in forms reporting severity of pain and other menstrual symptoms, as well as amount of menstrual bleeding on each day of menstrual cycle during 2 following months and the end of the 2 months give them to the researcher. 60 of the recruited people, who have good cooperation in reporting the symptoms, will be randomized using blocks sized 6 and 9 into 3 groups. One group will get capsule of calcium, the second combination of calcium and magnesium and the third one placebo which are identical in terms of size, colour, ... They will be instructed to use them from 15th day of menstruation cycle till end of following menstrual pain and fill in the similar questionnaire as the 2 previous months. They will be given Mefenamic acid capsules to use during the 4 months study cycles, if needed, but they have to report number of the capsules used. The groups will be compared in terms of mean pain score, symptom severity score, resting time, number of Mefenamic acid used, amount of blood menstruation using Covariance test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202013706N10
Registration date: 2012-05-13, 1391/02/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-05-13, 1391/02/24
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-05-14, 1391/02/25
Expected recruitment end date
2012-06-14, 1391/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of calcium with magnesium and only calcium on the pain severity and resting time with primary dysmenorrhea: a triple-blind randomized controlled trial
Public title
The effectiveness of calcium with magnesium and only calcium on the pain severity and resting lenght with primary dysmenorrhea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Single students aged 18-34 years residing in Aras dormitory, having primary dysmenorrhea, regular and painful menstruation in previous 1 year with pain score equal or more than 5 according to visual analogue scale (medium to severe dysmenorrhea); consent to participate the study Exclusion criteria: Known serious diseases like epilepsy, severe digestive disorders, cardiovascular or renal diseases, pelvic inflammatory diseases; consumption of oral contraceptive pills in previous 6 months or desire to take them during study; allergy to NSAIDs.
Age
From 18 years old to 34 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Deputy, Tabriz University of Medical Sciences
Street address
Golgasht
City
Tabriz
Postal code
Approval date
2012-01-16, 1390/10/26
Ethics committee reference number
9081

Health conditions studied

1

Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
primary dysmenorrhea

Primary outcomes

1

Description
mean severity of menstrual pain
Timepoint
for 2 months after intervention, 1 day before starting mensturation tol 3 days after it, measured once every 6 hours
Method of measurement
Visual Analogue Scale

2

Description
resting length due to dysmenorhea
Timepoint
for 2 months after intervention
Method of measurement
daily recording of resting length by the participants on a form

Secondary outcomes

1

Description
Symptom Severity during Mensturation
Timepoint
during 2 months after intervention
Method of measurement
Symptom Severity Scale

2

Description
Need to take additional pain relief drug for dysmenorrhea
Timepoint
for two months after starting intervention
Method of measurement
No of Mephenamic Capules used

3

Description
volume of menstural bleeding
Timepoint
for two months after starting intervention
Method of measurement
Higham table

Intervention groups

1

Description
Intervention 1: Taking Capsules containing 600 mg Calcium once a day from day 15 of menstural cycle to reliefing dysmenorrhea in the following cycle
Category
Treatment - Drugs

2

Description
Intervention 2: Taking Capsules containing 600 mg Calcium and 300 mg magnesium once a day from day 15 of menstural cycle to reliefing dysmenorrhea in the following cycle
Category
Treatment - Drugs

3

Description
Control group: Taking Placebo Capsules once a day from day 15 of menstural cycle to reliefing dysmenorrhea in the following cycle
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dormitories of Aras Branch- Tabriz University of Medical Sciences
Full name of responsible person
salimeh nezamivand-chegini
Street address
City
Aras

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences, Aras branch
Full name of responsible person
Dr. mahmood nazarpour
Street address
Next to Tourism Hotel, Jolfa
City
Jolfa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences, Aras branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences, Aras Unit
Full name of responsible person
Salime Nezamivand-Chegini
Position
Master student of Midwifery
Other areas of specialty/work
Street address
Next to Tourism Hotel, Jolfa
City
Jolfa
Postal code
Phone
00
Fax
Email
Nezamivandsalime@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Assistant professor, PhD in reproductive health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1479 7713
Fax
Email
alizades@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences - Nursing & Midwifery Faculty
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
PhD in reproductive health
Other areas of specialty/work
Street address
Shariatie Ave.
City
Tabriz
Postal code
Phone
+98 41 1479 7713
Fax
Email
alizades@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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