The aim of thise prospective intervention study wase to evaluate the effect of a single - loading oral dose of Cholecalciferol(300000IUs) ON Primary Dysmenorrhea. Fifty fore women aged 18 to 35 years with iclutions and exclutions criterias , attending the outpatient clinics of the Department of Internal Medicine of the University of Kermanshah , for pimary dysmenorrhea were enrolled. Women were randomized in to 2 groups: 27 women received a single oral dose of Cholecalciferol(300000IUs) 5 days before the putative beginning of their next menstrual cycle,while another 20 women received Placebo. The primary outcome was the intensity of menstrual pain as measured by a visual analog scale. The secondary outcome was use of NSAIDs during the 3-month duration of the study. They showed a 25(OH)D serum level. The study was performed between march 2012 and May 2013.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022312582N1
Registration date:2013-08-18, 1392/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Mina Ataee
Name of organization / entity
Medical Uneversity of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 1838 4158
Email address
ataee.mina@yahoo.com
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-05-21, 1392/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Improvement of Primary Dysmenorrhea
Caused by a Single Oral Dose of Vitamin D:
Results of a Randomized, Double-blind,
Placebo-Controlled Study
Public title
Effect of Single Oral Dose of Vitamin D in Primary Dysmenorhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclution Criterias :Their
menstrual cycles lasted 21 to 35 days; With menstruation
lasting 3 to 7 days; They experienced at least 4 consecutive
painful periods in the past 6 months with the pain starting
one day before or on the day of onset of bleeding;
They showed a 25(OH)D serum level;
Patients had to be in good health and taking no medications
including calcium, vitamin D, and oral contraceptives;Sonografy of ovary and utrian is normal in the past 6 months.
Exclutios Criteria: Had no Their
menstrual cycles lasted 21 to 35 days;had no With menstruation
lasting 3 to 7 days; They no experienced at least 4 consecutive
painful periods in the past 6 months with the pain starting
one day before or on the day of onset of bleeding;
Patients had no be in good health and taking medications
including calcium, vitamin D, and oral contraceptives; Sonografy of ovary and utrian is abnormal in the past 6 months.
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building No 2, Shahid Beheshty Blv, Medical Uneversity of Kermanshah
City
kermanshah
Postal code
Approval date
2012-11-21, 1391/09/01
Ethics committee reference number
1/420/7/پ
Health conditions studied
1
Description of health condition studied
primary dysmenorhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
2
Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
Primary outcomes
1
Description
The intensity of menstrual pain
Timepoint
before, 1 and 3 months after intervention
Method of measurement
visual analogue scale(VAS)
Secondary outcomes
1
Description
Use of NSAIDs
Timepoint
before, 1 and 3 months after intervention
Method of measurement
asking from subjects
Intervention groups
1
Description
The intervention group received a single oral dose of cholecalciferol (300 000 IUs) 5 days before the putative
beginning of their next menstrual cycle and NSAIDs.
Category
Treatment - Drugs
2
Description
The Placebo group received a placebo drug cholecalciferol 5 days before the putative
beginning of their next menstrual cycle and NSAIDs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Mina Ataee
Street address
Building No 2, Shahid Beheshty Blv, Medical Uneversity of Kermanshah
City
kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Basic Sciences, Kermanshah University of Medical Sciences
Full name of responsible person
Ms Faraj Roshanpoor
Street address
Building No 2, Shahid Beheshty Blv, Medical Uneversity of Kermanshah
City
kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Basic Sciences, Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences and Research
Full name of responsible person
Mina Ataee
Position
Resident of Gynecology and Obstetrics
Other areas of specialty/work
Street address
Building No 2, Shahid Beheshty Blv, Medical Uneversity of Kermanshah