Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202209735208004 Date of Approval: 01/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Efficacy of Using Chromium Salts in Reducing Hirsutism Scoring & BMI in Polycystic Ovary Syndrome Patients
Official scientific title The Efficacy of Using Chromium Salts in Reducing Hirsutism Scoring & BMI in Polycystic Ovary Syndrome Patients A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Polycystic ovary syndrome (PCOS) is one of the most frequent endocrinopathies in women in reproductive age and in adolescence. The causes of PCOS are still being studied; This study is designed to assess the effect of chromium salts in decreasing hirsutism scoring &and Body Mass Index in polycystic ovary syndrome patients. The study was conducted on (60) women diagnosed as having polycystic ovary syndrome with hyperandrogenism. On their visit to the clinic, PCOS patients were selected, counseled and consented to participate in the study. Women were distributed into 2 groups, both groups received metformin with dose of 500mg after main meal. The patients were grouped into 2 groups each one involved 30 patients: Group (S) (study): (n=30) chromium (chromium picolinate, Mepaco) was given orally in a dose of 200microgram /day for 4 months’ duration. Group (C) (control): (n=30) received placebo (in the form of c retard 500 mg capsules).then Follow Up was for the frequency of hair removal every month for 4 months duration with usage of temporary method of hair removal and was stopped before follow up date by 2 weeks. Follow up was also for BMI monthly (Body weight was measured using analogue scales in light clothes; height was measured barefoot using a stadiometer). Body mass index was calculated as follows: weight (kg)/height2 (m) Regularity of menses: The patient was asked about her menstrual history (time between cycles frequency ,duration) Any reported side effects of chromium salts or metformin: each month throughout the period of taking the drug every month for 4 months duration
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 26/11/2020
Actual trial start date 01/12/2020
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date 31/05/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group drug chromium (chromium picolinate, Mepaco) was given orally in a dose of 200microgram /day for 4 months’ duration. both groups received metformin with dose of 500mg after main meal. experimental group chromium (chromium picolinate, Mepaco) was given orally in a dose of 200microgram /day for 4 months’ duration. The patients were followed up for taking the drug regularly by phone calls every two weeks. Follow up was for the frequency of hair removal every month for 4 months duration with usage of temporary method of hair removal and was stopped before follow up date by 2 weeks.Follow up was also for BMI monthly (Body weight was measured using analogue scales in light clothes; height was measured barefoot using a stadiometer). Body mass index was calculated as follows: weight (kg)/height2 (m)  Regularity of menses: The patient was asked about hermenstrual history (time between cycles, frequency, duration)  Any reported side effects of chromium salts or metformin: each month throughout the period of taking the drug. 30
Control Group drug received placebo (in the form of c retard capsules). 500mg 4 months duration both groups received metformin with dose of 500mg after main meal. this group received placebo (in the form of c retard 500mg capsules). Follow Up: the same as the other group 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Cases of PCOS syndrome according to Rotterdam criteria: PCO syndrome could be diagnosed after exclusion of related disorders by 2 of the following 3 features:  Oligo or anovulation  Clinical and/or biochemical signs of hyperandrogenism  Polycystic ovaries by ultrasound features: Bilateral enlarged ovaries with multiple small follicles with  Increased ovarian volume (more than10cc)  12 or more follicles measuring (2-9mm)  Follicles of similar size  Peripheral location of the follicles which can give a string of pearl appearance Hyperechoic central stroma, thick cortex  The ovarian outline may be slightly irregular 2- Accept to participate and provide consent. 3- Females between 18-40 years of age with hirsutism. 1- Patient unwilling or unable to provide consent. 2- Female age below 18years and above 40years.3- Patients known to be diabetic or hypertensive. 4- Patients receiving corticosteroids, psychotropic drugs or diuretics 5- Patients receiving Ovulation induction drugs. 6- Usage of permanent methods of hair removal. Adult: 19 Year-44 Year 18 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/11/2020 Ain Shams University Faculty Of Medicine Ethical Research Committee
Ethics Committee Address
Street address City Postal code Country
38 el Abassia Next TO EL NOUR Mosque cairo none Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To correlate between hirsutism scoring with adding chromium salts as a supportive agent in polycystic ovary syndrome patients monthly for 4 months
Secondary Outcome  Effect on BMI  Regulation of menses  Side effects of chromium salts  Side effects of metformin monthly for 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Maternity Hospital 38 EL Abassia NEXT TO El NOUR mosque cairo none Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University Maternity Hospital Al abassia cairi Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University 38 EL Abassia square Next To El Nour Mosque cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ain Shams University 38 Elabassia square CAIRO Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Snosi drmarwasnosi@gmail.com +021200522228 Hadeq El Qubba
City Postal code Country Position/Affiliation
cairo Egypt lecturer of obstetrics and gynecology Ain Shams University
Role Name Email Phone Street address
Public Enquiries Marwa Snosi drmarwasnosi@gmail.com +021200522228 Hadeq El Qubba
City Postal code Country Position/Affiliation
cairo Egypt lecturer of obstetrics and gynecology Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Marwa Snosi drmarwasnosi@gmail.com +0201200522228 Haeque El qubba
City Postal code Country Position/Affiliation
cairo Egypt lecturer of obstetrics and gynecology Ain Shams University
Role Name Email Phone Street address
Principal Investigator Heba Eid Heba.mohammed211@outlook.com +201029297877 6th october
City Postal code Country Position/Affiliation
cairo Egypt resident of obstetrics and gynecology sharq elmadina hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data cannot be shared due to privacy issues Study Protocol data cannot be shared due to privacy issues availability upon request due to privacy issues
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/08/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/08/2022 Result - 28/08/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information