Clinical trial of the effect of vitamin D supplementation compared with the placebo on treatment and metabolic profiles in patients with endometrial hyperplasia
Objective: The aim of this study is to determine the effects of vitamin D supplementation on treatment and metabolic profiles including insulin resistance and lipid profiles in patients with endometrial hyperplasia. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with endometrial hyperplasia and aged 30 to 50 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with endometrial hyperplasia of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either vitamin D (n=30) or placebo (n=30). Vitamin D and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 16 weeks after the intervention. At the beginning and end of the intervention: 16 weeks. Outcomes: Response to treatment (primary outcomes), and insulin metabolism parameters and lipid profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606275623N86
Registration date:2016-07-01, 1395/04/11
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2016-05-24, 1395/03/04
Expected recruitment end date
2016-06-24, 1395/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of vitamin D supplementation compared with the placebo on treatment and metabolic profiles in patients with endometrial hyperplasia
Public title
Effect of supplementation in treatment of patients with endometrial hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with endometrial hyperplasia; aged 30 to 50 years. Exclusion criteria: Unwillingness to cooperate.
Age
From 30 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random assignment will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Approval date
2016-05-24, 1395/03/04
Ethics committee reference number
IR.Kaums.REC.1395.19
Health conditions studied
1
Description of health condition studied
Endometrial hyperplasia
ICD-10 code
E11.2
ICD-10 code description
Endometrial hyperplasia
Primary outcomes
1
Description
Response to treatment
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Elisa kit
2
Description
Triglycerides
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Cholesterol
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
HDL
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Total antioxidant
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Glutathione
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), once a week, for 16 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), once a week, for 16 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)