Protocol summary

Study aim
The effect of zinc sulfate and folic acid on endocrine indices, CRP and lipid profile in women with polycystic ovary syndrome
Design
Clinical trial with control group, double-blind, randomized, on 44 patients. The table of random numbers was used for randomization.
Settings and conduct
44 women who aged 18-40 years old with polycystic ovarian syndrome were included in the study according to Rotterdam criteria. Prior to intervention, laboratory factors such as fasting blood sugar (FBS), Dehydroepiandrosterone sulfate (DHEAS), Testosterone, Cholesterol, Triglycerides, High density lipoprotein (HDL) and Low-density lipoprotein (LDL) was measured in subjects. Patients were randomly divided into 4 groups using the random number table and the first group received 220 mg zinc sulfate, the second group were administered 5 mg folic acid, the third group received220 mg zinc sulfate plus 5 mg folic acid and the fourth group received placebo. All groups received medication or placebo daily for 8 weeks and were re-evaluated for laboratory tests.
Participants/Inclusion and exclusion criteria
1.Oligoovulation or / and anovulation; 2.Clinical symptoms (Ferriman-Gallwey score≥6 or Acne or Seborrhoeic) or biochemical hyperandrogenism; 3. Evidence of polycystic ovaries on ultrasound
Intervention groups
The final number of participants after considering the entry and exit criteria randomly and using a table of random numbers is divided into 4 groups and the first group 220 mg of zinc sulfate (containing 50 mg of zinc), the second group 5 mg of acid Folic acid, the third group will receive 220 mg of zinc sulfate (containing 50 mg of zinc) + 5 mg of folic acid and the fourth group, which is the control group, will receive a placebo daily for 8 weeks.
Main outcome variables
FBS; DHEAS; Testosterone; CRP; Cholesterol; LDL; HDL; TG; drug (folic acid + zinc sulfate)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200610047715N1
Registration date: 2020-12-27, 1399/10/07
Registration timing: retrospective

Last update: 2020-12-27, 1399/10/07
Update count: 0
Registration date
2020-12-27, 1399/10/07
Registrant information
Name
Elham Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3426 4005
Email address
esalarii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-12-01, 1397/09/10
Actual recruitment start date
2018-01-29, 1396/11/09
Actual recruitment end date
2019-01-29, 1397/11/09
Trial completion date
2019-01-30, 1397/11/10
Scientific title
The effect of zinc sulfate and folic acid on endocrine indices, CRP and lipid profile in women with polycystic ovary syndrome in 2017-18.
Public title
The effect of zinc sulfate and folic acid on endocrine indices, CRP and lipid profile in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Oligoovulation or / and anovulation Clinical symptoms (Ferriman-Gallwey score≥6 or Acne or Seborrhoeic) or biochemical hyperandrogenism Evidence of polycystic ovaries on ultrasound
Exclusion criteria:
Hyperprolactinoma Thyroid disease Cardiovascular diseases Kidney-liver and neoplastic diseases Type 2 diabetes Pregnancy or breastfeeding Absorption disorders Use of drugs such as anti-diabetic drugs, anti-obesity drugs, diuretics, OCP, steroid and hormonal drugs (at least 3-6 months) and drugs that interfere with folic acid (perimetamine, aspirin, carbamazepine, chloramphenicol, chlorothiazide, conjugated estrogens, forge , Hydrochlorothiazide, Methotrexate, Phenytoin, Phenobarbital, Sulfamethoxazole, Salicylate)
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Actual sample size reached: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table; to use a table of random numbers, the exact number of people in the community was first determined and coded in order. Then, to select sample people from the table, we randomly start from a point in the table in the direction of the row or column. The selected number is in fact the individual code of the community that is selected as the sample. We will continue to do this until a small number can be selected based on the number of sample people. After completing the sample size, the sampling work is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
All drugs and placebo were prepared in exactly the same drug form and packaged and coded in dark envelopes. As a result, the patient and the researcher were unaware of the group of people
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
No. 9, 53 Alley, Abuzar St., Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717715191
Approval date
2018-01-02, 1396/10/12
Ethics committee reference number
IR.RUMS.REC.1396.155

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
FBS
Timepoint
8 weeks after taking the drug
Method of measurement
BT4500

2

Description
Dehydroepiandrosterone sulfate
Timepoint
8 weeks after taking the drug
Method of measurement
ELISA reader

3

Description
Testosterone
Timepoint
8 weeks after taking the drug
Method of measurement
ELISA reader

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first group received 220 mg of zinc sulfate (containing 50 mg of zinc) daily for 8 weeks
Category
Treatment - Drugs

2

Description
Intervention group: the second group received 5 mg of folic acid daily for 8 weeks
Category
Treatment - Drugs

3

Description
Intervention group: the third group received 220 mg of zinc sulfate (containing 50 mg of zinc) plus 5 mg of folic acid daily for 8 weeks.
Category
Treatment - Drugs

4

Description
Control group: this group received a placebo daily for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rafsanjan Endocrine Clinic
Full name of responsible person
Mohammadreza Shafipour
Street address
Rafsanjan - Imam Ali Boulevard - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
mr.shafiepour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Shamsizadeh
Street address
Rafsanjan - Imam Ali Boulevard - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellery for Research and Technology, Rafsanjan 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

Person responsible for general inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Shafipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ali Ibn Abi Talib Hospital in Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0000
Email
mr.shafiepour@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Shafipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ali Ibn Abi Talib Hospital in Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0000
Email
mr.shafiepour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Shafipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ali Ibn Abi Talib Hospital in Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0000
Email
mr.shafiepour@gmail.com

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
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