Conditions: Polycystic Ovary Syndrome Hypovitaminosis D
Keywords: Vitamin D deficiency hypovitaminosis D Biodal 25 hydroxy Vitamin D 25hydroxyvitamin D 25(OH)D PCOS insulin resistance BMI chromium levels vitamin D 3 cholecalciferol 50,000 IU
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: yes

Brief summary:
This is a prospective double-blind, randomized, parallel-group, placebo-controlled trial designed to examine the effect of supplementation with 50,000 IU vitamin D3 for 3 months on Polycystic Ovary Syndrome (PCOS) prognosis, serum 25-Hydroxy Vitamin D (25(OH)D) level, serum chromium level, insulin resistance, and Body Mass Index (BMI), in 60 overweight Jordanian female patients diagnosed with PCOS and with hypovitaminosis D.

Detailed description:
This study is designed to assess the safety and efficacy of 50,000 IU vitamin D supplementation once weekly for 3 months on improvement in PCOS prognosis and improvement in serum 25(OH)D levels in 60 overweight Jordanian females (defined as having a BMI 25-30kg/m2), diagnosed with PCOS (based on Rotterdam criteria), and with hypovitaminosis D (defined as a serum 25(OH)D level \< 20 ng/mL), compared with placebo.

Evaluation of the safety and efficacy of the dosing regimen will be conducted over 6 study visits during which clinical and biochemical signs of PCOS as well as serum 25(OH)D level, serum chromium level, insulin resistance, and BMI will be evaluated.

The measurements will be collected as follows : day (-7) during screening , Day (0) base line measurements , Day (30) , Day(60), Day (90), day (104).

Arms:
arm 1: 50,000 IU Vitamin D3 tablet given orally once weekly for 3 months arm 2: Placebo tablet given orally once weekly for 3 months

Interventions: intervention 1: 50,000 IU vitamin D3 intervention 2: Placebo
Intervention descriptions: intervention 1: Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU intervention 2: Placebo film-coated tablet of Biodal 50,000 IU

Protocol document: