Clinical trial of the effect of folate 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 folate supplementation on treatment and metabolic profiles including insulin resistance and inflammatory factors 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 Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either folate (n=30) or placebo (n=30). Folate and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Response to treatment (primary outcomes), and insulin metabolism parameters and inflammatory factors (secondry outcomes) will be quantified at the study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704155623N107
Registration date:2017-05-12, 1396/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-12, 1396/02/22
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, Arak University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of folate 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Postal code
Approval date
2016-04-11, 1395/01/23
Ethics committee reference number
IR.ARAKMU.REC.1394.336
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
Biopsy
Secondary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
4
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention