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Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome (CEOR-04-08)

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ClinicalTrials.gov Identifier: NCT02164552
Recruitment Status : Unknown
Verified June 2014 by Mohammed-Salleh M. Ardawi, King Abdulaziz University.
Recruitment status was:  Recruiting
First Posted : June 16, 2014
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
Mohammed-Salleh M. Ardawi, King Abdulaziz University

Brief 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.

Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Dietary Supplement: Vitamin D3 pills Other: Placebo pills

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.

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Study Type : Observational
Estimated Enrollment : 340 participants
Time Perspective: Prospective
Official Title: Vitamin D Status in Relation to Insulin Sensitivity, Resistance and Inflammatory Response Among Saudi Women With Polycystic Ovary Syndrome
Study Start Date : January 2009
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Vitamin D3 pills
Vitamin D3 (cholecalciferol) supplementation (50,000 IU/week for 8 weeks) followed by 1000 IU/day for 16 weeks
Dietary Supplement: Vitamin D3 pills
Dietary supplement
Other Names:
  • Vitamin D3
  • (cholecalciferol)

Placebo pill
Placebo pills will be given 1 per week for 8 weeks followed by 1 per day for 16 weeks
Other: Placebo pills
Placebo pills similar in appearance and shape but without vitamin D




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 24 weeks ]
    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


Other Outcome Measures:
  1. Exploratory and safety outcome [ Time Frame: 24 weeks ]
    Other endpoints were changes in inflammatory markers (hs-CRP)

  2. Exploratory outcomes: lipid profile [ Time Frame: 24 weeks ]
    Other endpoints were changes in lipid profile (total cholesterol, HDL-c, LDL-c, and triglycerides)

  3. Exploratory outcomes: liver and renal function tests [ Time Frame: 24 weeks ]
    Other endpoints were changes in liver function tests [albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(ALP)]; renal function tests (cystatine C, uric acid, urea) and parathyroid hormone (PTH)

  4. Exploratory outcomes: glycemic control [ Time Frame: 24 weeks ]
    Other endpoints were changes in HbA1c, fasting plasma glucose and fasting plasma insulin

  5. Exploratory outcomes: vitamin D status [ Time Frame: 24 weeks ]
    Other endpoints were changes in serum 25-hydroxyvitamin D

  6. Exploratory outcomes: endocrine profile [ Time Frame: 24 weeks ]
    Other endpoints were changes in (follicle-stimulating hormone, luteinizing hormone, prolactin, thyroid-stimulating hormone, free thyroxine, total testosterone, dehydroepiandrosterone (DHEA), DHEA sulfate, delta 4-androstenedione and sex-hormone binding globulin).



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

PCOS diagnosis to include three of the Rotterdam criteria

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164552


Contacts
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Contact: Mohammed-Salleh M Ardawi, PhD, FRCPath 00966505616804 msmardawi@yahoo.com
Contact: Abdulrahim A Rouzi, FRCPC 00966505602587 aarouzi@gmail.com

Locations
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Saudi Arabia
Center of Excellence for Osteoporosis Research, King Abdulaziz University Recruiting
Jeddah, Makkah, Saudi Arabia, 21589
Contact: Veronica B Orbacedo, BSc    0096612640000 ext 25574    vorbacedo@yahoo.com   
Contact: Ramia Al-sobhi, BSc    0096612640000 ext 25528    ceor@kau.edu.sa   
Sub-Investigator: Ahmed Y Ali, MD         
Sub-Investigator: Ghazi Y Refai, MD         
Sub-Investigator: Mohammed H Qari, FRCPA         
Sub-Investigator: Heba S Kary, MD         
Sponsors and Collaborators
King Abdulaziz University
Investigators
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Principal Investigator: Abdulrahim A Rouzi, FRCPC Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz University
Study Director: Mohammed-Salleh M Ardawi, PhD, FRCPath Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University
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Responsible Party: Mohammed-Salleh M. Ardawi, Professor, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT02164552    
Other Study ID Numbers: CEOR-04-08
Vitamin D PCOS ( Other Grant/Funding Number: CEOR/001-08 and CEOR/004-08 )
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014
Keywords provided by Mohammed-Salleh M. Ardawi, King Abdulaziz University:
PCOS
vitamin D
insulin resistance
glycemic control
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents