Polycystic Ovary SyndromeCEOR-04-08NCT02164552
Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS will improve insulin sensitivity and resistance and inflammatory response to PCOS. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Vitamin D3 pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2009to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women were recruited through Infertility clinics at King Abdulaziz University Hospital, New Jeddah Clinic Hospital and Dr S Fakeeh Hospital, Jeddah area during general health survey and consecutively referred to a special clinic at the Center of Excellence for Osteoporosis Research for enrollment at the present study
Who may be able to join
- PCOS diagnosis to include three of the Rotterdam criteria
Who cannot join
- pregnancy lactation taking vitamin d or calcium supplement in excess of a regular multivitamins diabetes mellitus uncontrolled hypertension liver disease renal disease secondary causes of hyperandrogenism metabolic bone disease thyroid dysfunction taking oral contraceptives taking hypoglycemic agents (metformin or thiazolidinediones) medication to affect plasma sex steroids for >/3 months before the study smokers
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Center of Excellence for Osteoporosis Research, King Abdulaziz University
Jeddah, Mecca Region, 21589
Veronica B Orbacedo, BSc, 0096612640000 ext. 25574, vorbacedo@yahoo.com
Ramia Al-sobhi, BSc, 0096612640000 ext. 25528, ceor@kau.edu.sa
About this study
Official title: Vitamin D Status in Relation to Insulin Sensitivity, Resistance and Inflammatory Response Among Saudi Women With Polycystic Ovary Syndrome
The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS will improve insulin sensitivity and resistance and inflammatory response to PCOS.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a common complex and heterogenous endocrine disorder. It affects ≤10% of women of reproductive age, with approximately 16%-80% of the affected women being obese. Polycystic ovary syndrome frequently is associated with insulin resistance (IR) accompanied by compensatory hyperinsulinemia, and IR is aggravated by the interaction between obesity and the syndrome. Moreover, the contribution of body mass and/or body fat distribution to IR of PCOS remains controversial. In addition, women with PCOS with IR are at an increased risk of developing diabetes, hypertension, dyslipidemia and atherosclerosis. Preliminary data on the local women with PCOS showed high prevalence of vitamin D deficiency (serum 25(OH)D < 50 nmol/L). Recent studies showed that vitamin D deficiency is linked to IR, type 2 diabetes mellitus, obesity, inflammation and cardio vascular disease. Several studies have demonstrated that serum 25(OH)D levels were negatively correlated with body mass index (BMI), body fat, and IR. These conditions are common among women with PCOS. Accordingly, it is anticipated that vitamin D deficiency and/or insufficiency may contribute to the endocrine and metabolic disarrangements among women with PCOS. Such adverse effects may further contribute to the risk of further long term complications among women with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Vitamin D3 pills, Placebo pills
- Keywords
- PCOS, vitamin D, insulin resistance, glycemic control
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 pillsDietary supplement
Also called Vitamin D3, (cholecalciferol)
Dietary supplement
Placebo pillsOther
Placebo pills similar in appearance and shape but without vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 pills | Vitamin D3 (cholecalciferol) supplementation (50,000 IU/week for 8 weeks) followed by 1000 IU/day for 16 weeks Receives: Dietary Supplement: Vitamin D3 pills | |
| Placebo pill | Placebo pills will be given 1 per week for 8 weeks followed by 1 per day for 16 weeks Receives: Other: Placebo pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of vitamin D deficiency improves insulin resistance compared to placebo
The primary endpoint was an improvement in insulin resistance parameters [Fasting serum insulin,glucose-to-insulin ratio (GIR) and homeostasis model assessment (HOMA) ] from baseline and at 24 weeks in vitamin D supplemented as compared with placebo groups.
Measured: 24 weeks
Secondary outcomes (1)
Insulin sensitivity
Secondary endpoints were changes in parameter of insulin sensitivity[ quantitative insulin sensitivity check index (QUICKI)], among vitamin D supplemented group vs placebo group from baseline and at the end of the trial
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJan 2009
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed-Salleh M. Ardawi, King Abdulaziz University
- Investigators
- Abdulrahim A Rouzi, FRCPC, Principal investigator, Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz UniversityMohammed-Salleh M Ardawi, PhD, FRCPath, Study director, Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164552
- Sponsor's protocol ID
- CEOR-04-08
- Other IDs
- Vitamin D PCOS
- Acronym
- CEOR-04-08
- Status last verified
- Jun 2014
- First submitted
- 10 Jun 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status in Relation to Insulin Sensitivity, Resistance and Inflammatory Response Among Saudi Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02164552
- Acronym / sponsor ID
- CEOR-04-08 / CEOR-04-08
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, vitamin D, insulin resistance, glycemic control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS will improve insulin sensitivity and resistance and inflammatory response to PCOS.
Detailed description
Polycystic ovary syndrome (PCOS) is a common complex and heterogenous endocrine disorder. It affects ≤10% of women of reproductive age, with approximately 16%-80% of the affected women being obese. Polycystic ovary syndrome frequently is associated with insulin resistance (IR) accompanied by compensatory hyperinsulinemia, and IR is aggravated by the interaction between obesity and the syndrome. Moreover, the contribution of body mass and/or body fat distribution to IR of PCOS remains controversial. In addition, women with PCOS with IR are at an increased risk of developing diabetes, hypertension, dyslipidemia and atherosclerosis. Preliminary data on the local women with PCOS showed high prevalence of vitamin D deficiency (serum 25(OH)D < 50 nmol/L). Recent studies showed that vitamin D deficiency is linked to IR, type 2 diabetes mellitus, obesity, inflammation and cardio vascular disease. Several studies have demonstrated that serum 25(OH)D levels were negatively correlated with body mass index (BMI), body fat, and IR. These conditions are common among women with PCOS. Accordingly, it is anticipated that vitamin D deficiency and/or insufficiency may contribute to the endocrine and metabolic disarrangements among women with PCOS. Such adverse effects may further contribute to the risk of further long term complications among women with PCOS.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 pills | – | Dietary Supplement: Vitamin D3 pillsVitamin D3 (cholecalciferol) supplementation (50,000 IU/week for 8 weeks) followed by 1000 IU/day for 16 weeks |
| Placebo pill | – | Other: Placebo pillsPlacebo pills will be given 1 per week for 8 weeks followed by 1 per day for 16 weeks |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women were recruited through Infertility clinics at King Abdulaziz University Hospital, New Jeddah Clinic Hospital and Dr S Fakeeh Hospital, Jeddah area during general health survey and consecutively referred to a special clinic at the Center of Excellence for Osteoporosis Research for enrollment at the present study
Key inclusion criteria (1 listed)
- PCOS diagnosis to include three of the Rotterdam criteria
Key exclusion criteria (1 listed)
- pregnancy lactation taking vitamin d or calcium supplement in excess of a regular multivitamins diabetes mellitus uncontrolled hypertension liver disease renal disease secondary causes of hyperandrogenism metabolic bone disease thyroid dysfunction taking oral contraceptives taking hypoglycemic agents (metformin or thiazolidinediones) medication to affect plasma sex steroids for >/3 months before the study smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 pillsAlso: Vitamin D3, (cholecalciferol)Dietary supplement | Dietary supplement | Vitamin D3 pills |
| Placebo pillsPlacebo pills similar in appearance and shape but without vitamin D | Other | Placebo pill |
Primary outcome
Correction of vitamin D deficiency improves insulin resistance compared to placebo
Time frame: 24 weeks
The primary endpoint was an improvement in insulin resistance parameters [Fasting serum insulin,glucose-to-insulin ratio (GIR) and homeostasis model assessment (HOMA) ] from baseline and at 24 weeks in vitamin D supplemented as compared with placebo groups.
1 secondary outcome
Insulin sensitivity
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdulrahim A Rouzi, FRCPC principal investigator
Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz University
Mohammed-Salleh M Ardawi, PhD, FRCPath study director
Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed-Salleh M Ardawi, PhD, FRCPath (00966505616804, msmardawi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correction of vitamin D deficiency improves insulin resistance compared to placebo (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2014.