Clinical Research Details

Descriptive Information
The Effect of Vitamin D, Atorvastatin, and Fluvastatin on Cardiovascular Disease Risk Factors in Women with Polycystic Ovary Syndrome: A Prospective Randomized Controlled Parallel: Three Arm Trial.

Ghina Ghazeeri


Clinical Research - Therapeutic interventions  

Phase 2  

  • Anwar Nassar, MD
  • Ghada El-Hajj Fuleihan, MD, MPH
  • Dima Jeha, MD
  • Johnny Awwad, MD
  • Anthony Msan,MPH
Fatin Khalifeh
Extension: 5618
Conditions and Keywords
Polycystic Ovary Syndrome,Cardiovascular disease
Polycystic Ovary Syndrome,Atorvastatin,Vitamin D,Fluvastatin,Cardiovascular disease risk factors
Study Design
Pharmacokinetics and/or Pharmacodynamics
N/A: Not Applicable
Eligibility and IRB
Min: 18
Max: 35

In this study we will therefore directly compare the effects of VD, Atorvastatin (increases 25-OHD), and Fluvastatin (which does not increase 25-OHD), on CVD risk factors in women with PCOS.

These investigations may clarify whether the clinical benefits of statins are mediated through the protective effect of increased VD levels, rather than or as well as lipid lowering. This may refute or justify VD supplementation alone, the prescription of a specific type of statin, or even replacement of statin expensive treatment by VD, a safe and affordable drug, in women with PCOS. 

Adult women with PCOS attending the Women’s Health Center (WHC) and the outpatient Obstetrics and Gynecology clinics (OPD) at the American University of Beirut Medical Center (AUBMC) in Beirut, Lebanon.

purposeful sampling

-          Women between 18-35 years of age meeting the criteria for the diagnosis of PCOS according to the Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group.

-          Not planning to conceive and using non – hormonal method for contraception (barrier method).

-          No concurrent illness and not on any prescription or over the counter medication or vitamin that was likely to affect insulin sensitivity, lipids, vitamin D, including hormonal contraception for the preceding 6 months.

-          No prior statin therapy in the last 6 months.

-          Thyroid disease

-          Hyperprolactinemia (>30 ug/l)

-          Cushing’s disease

-          Androgen secreting tumors

-          Non classical 21-hydroxylase deficiency

-          Chronic medical illness (liver, kidney disease)

-          Previously known to have kidney stones

-          Diagnosis of cancer

-          Taking a drug that affects inflammatory markers: Aspirin, Non- Steroidal Inflammatory Drugs, etc….

-          Taking lipid or glucose lowering drugs: xenical, fibers, acarbose, metformin within the last 6 months, etc...

-          Taking vitamin D supplements

-          Pregnancy