Clinical trial of the effect of chromium supplementation compared with the placebo on gene expression related to insulin and lipid in women with polycystic ovary syndrome candidate for IVF
The aim of this study is to determine the effects of chromium supplementation on gene expression related to insulin and lipid in patients with polycystic ovary syndrome candidate for IVF.
Design
Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive chromium supplements (n=20) or placebo (n=20)
Settings and conduct
Among patients with polycystic ovary syndrome candidate for IVF referred to Taleghani Clinic affiliated to Shahid Beheshti University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with polycystic ovary syndrome candidate for IVF aged 18 to 40 years. Exclusion criterion: unwillingness to cooperate.
Intervention groups
Intervention group: Chromium supplements (21st Century, Arizona, USA), 200 µg, daily, for 8 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) once a day for 8 weeks orally.
Main outcome variables
Gene expression related to insulin (primary outcomes) and gene expression related to lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N32
Registration date:2018-04-05, 1397/01/16
Registration timing:retrospective
Last update:2018-04-05, 1397/01/16
Update count:1
Registration date
2018-04-05, 1397/01/16
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-27, 1396/12/08
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of chromium supplementation compared with the placebo on gene expression related to insulin and lipid in women with polycystic ovary syndrome candidate for IVF
Public title
Effect of chromium supplementation in treatment of patients with polycystic ovary syndrome candidate for IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with polycystic ovary syndrome
Individuals aged 18 to 40 years old
Exclusion criteria:
Unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y), subjects will be randomly divided into two groups to receive supplement or placebo. 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1771844351
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.1292
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
Polycystic
ICD-10 code description
E28.2
Primary outcomes
1
Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of GLUT-1 gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
Secondary outcomes
1
Description
Expressed levels of ox-LDL gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of LP(a) gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
Intervention groups
1
Description
Intervention group: Chromium supplements (21st Century, Arizona, USA), 200 µg, daily, for 8 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran) once a day for 8 weeks orally.