Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000780954
Ethics application status
Approved
Date submitted
23/07/2011
Date registered
26/07/2011
Date last updated
5/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin D in women with polycystic ovary syndrome
Scientific title
Vitamin D and clomiphene citrate versus clomiphene citrate only for ovulation induction in women with PCOS: A randomized double-blind, placebo-controlled clinical trial
Secondary ID [1] 262689 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D in women with polycystic ovary syndrome 268392 0
Condition category
Condition code
Metabolic and Endocrine 268533 268533 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All women with PCOS who fullfiled the criteria and agreed to participate in the study will be randomized (by computer-generated randomization) into two groups. Group 1 will be treated with Vitamin D 50000 units once orally for the first week followed by 1000 units orally daily for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate daily orally for five days from day three of the menstrual period. Group 2 will be treated with placebo once orally in the first week followed by placebo daily orally for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate daily orally for five days from day three of menses. Ovulation is confirmed by midluteal serum P values of > 8.0 ng / ml.
Intervention code [1] 267035 0
Treatment: Drugs
Comparator / control treatment
The placebo is identical in taste and appearance to Vitamin D tablet but without the active ingredient
Control group
Placebo

Outcomes
Primary outcome [1] 269277 0
Ovulation rate as determined by day 21 progesterone
Timepoint [1] 269277 0
3 menstrual cycles
Secondary outcome [1] 279277 0
Determination of Vitamin D, metabolic, hormonal, inflammatory and endothelial markers, and insulin resistance in women with PCOS after treatment with Vitamin D and clomiphene citrate or clomiphene citrate and placebo
Timepoint [1] 279277 0
3 menstrual cycles

Eligibility
Key inclusion criteria
Women attending the infertility clinics at King Abdulaziz University Hospital. PCOS is being defined as any women with two out of three criteria 1). Oligo- or anovulation; 2). Clinical and/or biochemical signs of hyperandrogenism; and 3). Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, and Cushing's syndrome)
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to participate in the study
Male factor infertility
Fallopian tubal disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
During the first visit to the infertility clinics, a thorough routine general medical, menstrual, and obstetrical history will be taken. In addition, a general physical and gynecologic examination will be performed including the woman’s height, weight and waist. The body mass index (BMI) will be calculated for the grading of obesity and waist-to-hip ratio (WHR) will also be determined. Women with history and physical examination suggestive of PCOS (infertility, oligomenorrhea, menstrual irregularities, hairsutism, and obesity) will be requested to have hormonal profile. Hormonal profile will be done in the laboratory services of KAUH. It will include: prolactin, TSH, free T4, LH, FSH, DHEA, DHEAs, T, free T, 17-OHP and Andresterone (A). Semen analysis will be done in the laboratory services of KAUH. Moreover, tests of tubal patency (hysterosalpingography and laparoscopy) will be performed as indicated. The obtained information and results will be recorded on a standardized forms developed for the purpose of this research project.
All women included in this part will have a transvaginal ultrasound scans of the ovaries (this will be performed by experienced sonographer at KAUH). The presence of polycystic ovaries will be diagnosed by the presence of 12 or more follicles in each ovary measuring 2-9 nm in diameter, and/or increased ovarian volume > 10 cm3 according to international standards.

All women with PCOS who fullfiled the criteria and agreed to participate in the study will be randomized (by computer-generated randomization) assigned by sealed opaque envelopes into two groups. Group 1 will be treated with Vitamin D 50000 units orally for the first week followed by 1000 units daily for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate for five days from day three of the menstrual period. Group 2 will be treated with placebo for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate for five days from day three of menses. Ovulation is confirmed by midluteal serum P values of > 8.0 ng / ml.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers assigned by sealed opaque envelopes into two groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3745 0
Saudi Arabia
State/province [1] 3745 0

Funding & Sponsors
Funding source category [1] 267509 0
University
Name [1] 267509 0
King Abdulaziz University
Country [1] 267509 0
Saudi Arabia
Primary sponsor type
University
Name
King Abdulaziz University
Address
PO Box 80215
Jeddah 21589
Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 266550 0
None
Name [1] 266550 0
Address [1] 266550 0
Country [1] 266550 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269472 0
The Bioethical and Research Committee
Ethics committee address [1] 269472 0
PO Box 80215
Jeddah 21589
Saudi Arabia
Ethics committee country [1] 269472 0
Saudi Arabia
Date submitted for ethics approval [1] 269472 0
01/05/2009
Approval date [1] 269472 0
27/06/2009
Ethics approval number [1] 269472 0
1/09/0276

Summary
Brief summary
All women with PCOS who fullfiled the criteria and agreed to participate in the study will be randomized (by computer-generated randomization) into two groups. Group 1 will be treated with Vitamin D 50000 units orally for the first week followed by 1000 units daily for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate for five days from day three of the menstrual period. Group 2 will be treated with placebo for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate for five days from day three of menses. Ovulation is confirmed by midluteal serum P values of > 8.0 ng / ml.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 32915 0
Prof Abdulrahim Rouzi
Address 32915 0
[email protected]
Country 32915 0
Saudi Arabia
Phone 32915 0
+966505602587
Fax 32915 0
Email 32915 0
[email protected]
Contact person for public queries
Name 16162 0
Prof Abdulrahim A. Rouzi
Address 16162 0
PO Box 80215
Jeddah 21589
Saudi Arabia
Country 16162 0
Saudi Arabia
Phone 16162 0
966505602587
Fax 16162 0
96626408316
Email 16162 0
[email protected]
Contact person for scientific queries
Name 7090 0
Prof Abdulrahim A. Rouzi
Address 7090 0
PO Box 80215
Jeddah 21589
Saudi Arabia
Country 7090 0
Saudi Arabia
Phone 7090 0
966505602587
Fax 7090 0
96626408316
Email 7090 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.