Goal : Comparison of pain recurrence between prescription and not prescription of vitamin D after laparoscopic surgery in patients with endomeriosis.
If results of prescription and not prescription of vitamin D on recurrence of endometriotic pains had significant difference, it can be beneficial on treatment of endomeriosis.
Inclusion criteria : 15-45 years women that during laparoscopy endometriosis is confirmed and in second menstruation after operation the score of pain for dysmenorrhea or pelvic pain will be 3 or more.
Exclusion criteria : The women that have received vitamin D in last 6 months, the women that will not continue the follow up.
Research population : The women with endometriosis that in second menstruation after operation have pain score 3 or more.
Sample size : 11 patients in each group ( total = 22 )
Intervention : Prescription and not prescription of vitamin D
In vitamin D group from 2 cycles after operation for 16 weeks will tack 50000 IU vitamin D ( Dana Tabriz - Iran ) weekly and in non vitamin D prescription group placebo each week until 16 weeks.
Primary results : Pelvic pain and dysmenorrhea between 2 groups will be compared 6 months after operation.
General information
Acronym
vitamin D and endometriosis
IRCT registration information
IRCT registration number:IRCT2013021912151N3
Registration date:2014-09-23, 1393/07/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-23, 1393/07/01
Registrant information
Name
Fariba Almassinokiani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2202 4187
Email address
f-almasi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Minimally invasive surgery research center , Iran University of Medical Sciences
Expected recruitment start date
2014-09-01, 1393/06/10
Expected recruitment end date
2015-10-02, 1394/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing between prescription and not prescription of vitamin D on recurrence of endometriosis related pains, after laparoscopic surgery
Public title
Comparing between prescription and not prescription of vitamin D on recurrence of endometriosis related pains
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 15-45 years women that during laparoscopy endometriosis is confirmed and in second menstruation after operation the score of pain for dysmenorrhea or pelvic pain will be 3 or more.
Exclusion criteria : The women that have received vitamin D in last 6 months, the women that will not continue the follow up.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
22
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
Iran University of Medical Sciences
Street address
Tehran,Hemmat pathway
City
Tehran
Postal code
Approval date
2014-08-31, 1393/06/09
Ethics committee reference number
93-02-140-24388-103892
Health conditions studied
1
Description of health condition studied
Endometriosis of pelvic peritoneum
ICD-10 code
N80.3
ICD-10 code description
Endometriosis of pelvic peritoneum
Primary outcomes
1
Description
Severity of dysmenorrhea
Timepoint
2 cycles after operation
Method of measurement
VAS test
2
Description
Severity of dysmenorrhea
Timepoint
before operation
Method of measurement
VAS test
3
Description
Severity of dysmenorrhea
Timepoint
4 months after starting vitamin D
Method of measurement
VAS test
Secondary outcomes
1
Description
dysmenorrhea
Timepoint
4 months after starting vitamin D
Method of measurement
VAS test
Intervention groups
1
Description
In intervention group oral pearls of vitamin D ( 50000 IU - Dana Tabriz Company-Iran ) per week until 16 weeks after operation will be prescribed.
Category
Treatment - Drugs
2
Description
in control group one oral pearl of placebo ( 50000 IU - Dana Tabriz Company-Iran ) weekly until 16 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital
Full name of responsible person
Dr.Fariba Almassi
Street address
Iran , Tehran , Sattarkhan street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Minimally Invasive Surgery Research Center of Iran University of Medical Sciences
Full name of responsible person
Dr Fariba Almassi
Street address
Tehran , Rasoul-e-Akram Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Minimally Invasive Surgery Research Center of Iran 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
Iran University of Medical Sciences ( IUMS )
Full name of responsible person
Dr Fariba Almassi
Position
Obstetrician and Gynecologist , Fellw ship of laparoscopy
Other areas of specialty/work
Street address
Sattarkhan street , Rasoul-e-Akram Hospital , Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 6650 9283
Fax
+98 21 6650 9283
Email
dralmassi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences ( IUMS )
Full name of responsible person
Fariba Almassi. MD
Position
Associate Professor of Iran University of Medical Sciences
Other areas of specialty/work
Street address
Sattarkhan street , Rasoul-e-Akram Hospital , Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 6650 9283
Fax
+98 21 6650 9283
Email
dralmassi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences ( IUMS )
Full name of responsible person
Dr.Fariba Almassi
Position
Associate Profesor of Iran University of Medical Sciences
Other areas of specialty/work
Street address
Sattarkhan street , Rasoul-e-Akram Hospital , Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 6650 9283
Fax
+98 21 6650 9283
Email
dralmassi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)