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.: PACTR201611001856174 Date of Approval: 09/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Chromium Supplementation in Women with Clomiphene Citrate-Resistant Polycystic Ovary Syndrome
Official scientific title Effect of Chromium Supplementation in Women with Clomiphene Citrate-Resistant Polycystic Ovary Syndrome
Brief summary describing the background and objectives of the trial Polycystic ovarian syndrome (PCOS) is a highly prevalent hormonal and metabolic disorder among reproductive-age women worldwide;[1] it is estimated to affect 5-10% of women at reproductive age.Both obese and lean women with PCOS have been demonstrated to have some degree of insulin resistance. However, obese women with PCOS are more insulin resistant than either lean women with PCOS or obese women without PCOS.Early preclinical reports suggested that chromium enhances insulin binding, insulin receptor number, and ¿-cell sensitivity, and reported the isolation of a protein termed chromodulin that linked chromium to receptor signaling.[10] Chromium picolinate (CrP) is the most popular of chromium-containing nutritional supplements.A considerable number of studies have evaluated chromium in clinical research trials over the past 40 years. However, many of the studies were difficult to interpret, as many were open-label studies and therefore generated substantial bias.[11] Thus, this randomized clinical trial aims to investigate the effect of combining clomiphene with chromium picolinate supplementation on ovulation induction in clomiphene citrate-resistant patients with PCOS.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) chromium pcos
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Polycystic Ovarian Syndrome, PCOS
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Devices
Anticipated trial start date 07/04/2013
Actual trial start date 07/04/2013
Anticipated date of last follow up 03/11/2013
Actual Last follow-up date 29/12/2013
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 The participants were randomized with a computer generated list using Microsoft Excel ver. 2010 in a 1:1 ratio into two groups. computer generated list using Microsoft Excel ver. 2010 in a 1:1 ratio into two groups. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group clomiphene citrate dose 100mg for 3 cycles starting from day 3 to day 7 3 menstrual cycles Clomiphene citrate 50
Experimental Group Chromium picolinate 1000ug for 3 cycles 3 menstrual cycles Chromium picolinate in addition to clomiphene citrate 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
PCOS Age 18-40 clomiphene citrate resistant Infertile Thyroid hypo/hyperfunction Hyperprolactinemia Cushing syndrome) Others factors causing infertility Fasting hyperglycemia Elevated liver enzymes History of cardiac disease. Adolescent: 13 Year-18 Year,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 10/03/2013 Cairo University
Ethics Committee Address
Street address City Postal code Country
Al-Saray Street, El Manial Cairo 11956 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ovulation rate after 3-cycle treatment Ovulation was confirmed each cycle using a mid-luteal serumprogesterone level that was ¿ 5 ng/ml.
Secondary Outcome Secondary outcome measures were the effect of chromium supplementation on insulin, FSH and LH levels after treatment. Day 3 of the menstrual cycle after 3 cycles treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University- Kasr Alaini Hospital Al-Saray Street, El Manial Cairo 11956 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University- Kasr Alaini hospital Al-Saray Street, El Manial Cairo 11956 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mahmoud Mohamed Kotb New Nerco (Alshattr Alkhames) Degla, Maadi Cairo 11435 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mahmoud Mohamed Kotb kotbmmk@yahoo.com 0201000560568 New Nerco ( Alshattr Alkhames) Degla Maadi
City Postal code Country Position/Affiliation
Cairo 11435 Egypt Lecturer of Obstetrics and Gynecology- Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Mahmoud Mohamed Kotb kotbmmk@yahoo.com 0201000560568 New Nerco ( Alshattr Alkhames) Degla Maad
City Postal code Country Position/Affiliation
Cairo 11435 Egypt Lecturer of Obstetrics and Gynecology- Cairo Universit
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mahmoud Mohamed Kotb kotbmmk@yahoo.com 0201000560568 New Nerco ( Alshattr Alkhames) Degla Maad
City Postal code Country Position/Affiliation
Cairo 11435 Egypt Lecturer of Obstetrics and Gynecology- Cairo Universit
REPORTING
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