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.: PACTR201506001153655 Date of Approval: 30/05/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Chromium supplementation in polycystic ovarian syndrome cases.
Official scientific title Effect of chromium supplementation on insulin resistance and weight reduction in polycystic ovarian syndrome cases.
Brief summary describing the background and objectives of the trial Approximately 50% to 70% of all women with polycystic ovary syndrome (PCOS) have some degree of insulin resistance which contributes to hyperandrogenism responsible for the signs and symptoms of PCOS. Obesity worsens insulin resistance and is present in 50% of PCOS subjects . Metformin and thiazolidinediones have gained acceptance for treatment of PCOS-associated insulin resistance to induce ovulation Unfortunately, they could have adverse effects. Chromium picolinate, improves insulin sensitivity at the insulin receptor level and has been devoid of adverse effects but there are conflicting reports on its efficacy in assisting ovulation stimulation. We aim to prove that chromium could be beneficial in improving the body mass index and pregnancy rate in polycystic ovarian syndrome patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied polycystic ovary syndrome patients,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2014
Actual trial start date 30/05/2014
Anticipated date of last follow up 30/01/2015
Actual Last follow-up date 15/03/2015
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size of 4 and the block size was not variable) Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Chromium group 600mcg per day Three months Dietry product, Anti- estrogen 50
Control Group Controls Placebo Three months 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Body mass index between 30kg /m2 and 34.5 kg/m2 -12 or more small follicles should be seen in an ovary on ultrasound examination oriented in the periphery, giving the appearance of a 'string of pearls'. - Increased size of the ovaries, that is, 1.5 to 3 times larger than normal. Women with Polycystic ovarian syndrome and on diet or using metformin 23 Year(s) 31 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 30/05/2014 Alexandria Faculty of Medicine Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Azaritta Alexandria 21516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Insulin resistance HOMA-IR will be calculated for three cycles
Primary Outcome Follicular growth maturation at day 11 of the cycle, for three cycles.
Secondary Outcome Body mass index (BMI) every month for three months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shabtby Maternity hospital Port Said street Alexandria Egypt
Fleming Maternity clinic Tamaseen street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Alexandria Port Said street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obstetrics and Gynaecology Port Said street Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Eman Abd el fattah 4 Fathia Baheeg Fleming Alexandria Egypt
Hanan Naser Port Said street Alexandria Egypt
Nahla Farook Fleming Maternity Clinic Alexandria Egypt
Amani EL Sayed Fleming Maternity Clinic Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Abd el fattah eman0eman0eman7@gmail.com 00201228434181 4 Fathia Baheeg Fleming
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Tamer Abd El Daiem tmdaiem@yahoo.com 00201226720766 50 Raml Station
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Obstetrics and Gynaecology
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information