Protocol summary
-
Study aim
-
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.
-
Design
-
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.
-
Settings and conduct
-
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.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Patients with endometrial hyperplasia and aged 35–55 years old will be included in this study. Exclusion criteria: Menopausal women, history of cardiovascular disease, diabetes mellitus, fasting plasma glucose (FPG) > 126 mg/dL, consumption of antihyperglycemic agents including metformin, triglycerides levels > 500 mg/dL, systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 110 mmHg and untreated thyroid disease
-
Intervention groups
-
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.
-
Main outcome variables
-
Outcomes: Response to treatment (primary outcomes), and insulin metabolism parameters, lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT201606275623N86
Registration date:
2016-07-01, 1395/04/11
Registration timing:
retrospective
Last update:
2019-09-22, 1398/06/31
Update count:
1
-
Registration date
-
2016-07-01, 1395/04/11
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for research, Kashan University of Medical Sciences
-
Expected recruitment start date
-
2016-05-25, 1395/03/05
-
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:
Aged 35 to 55 years
Patients with endometrial hyperplasia
informed consent
Exclusion criteria:
Menopausal women
History of cardiovascular disease
Diabetes mellitus
Fasting plasma glucose (FPG) > 126 mg/dL
Consumption of antihyperglycemic agents including metformin
Triglycerides levels > 500 mg/dL
Systolic blood pressure ≥ 160 mmHg
Diastolic blood pressure ≥ 110 mmHg
Untreated thyroid disease
-
Age
-
From 35 years old to 55 years old
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take vitamin D supplementation (n=30) or placebo (n=30). Randomization will be done by the use of computer-generated random numbers.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
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 12 weeks of intervention
-
Method of measurement
-
Sonography
Secondary outcomes
1
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Elisa kit
2
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
3
-
Description
-
Cholesterol
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
4
-
Description
-
HDL
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
5
-
Description
-
Total antioxidant
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
6
-
Description
-
Glutathione
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
7
-
Description
-
Malondialdehyde
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
8
-
Description
-
Nitric oxide
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
9
-
Description
-
Insulin resistance
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Using HOMA formula
10
-
Description
-
VLDL cholesterol
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
Intervention groups
1
-
Description
-
Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), once a week, for 12 weeks orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo (Barij Essence, Kashan, Iran), once a week, for 12 weeks orally.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
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
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available