The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance Among Overweight Jordanian Women With Polycystic Ovary Syndrome in Irbid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328404
• Other study ID #: VitD31.0
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2014
• Last updated: April 14, 2015
• Start date: February 2014

Study information

• Verified date: December 2014
• Source: Hayat Pharmaceutical Co. PLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Jordanian Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effect of 50,000 IU vitamin D3 supplementation on Polycystic Ovary Syndrome prognosis.

A randomized, double-blind, Parallel design comparing vitamin D with Placebo will be conducted on 60 overweight females diagnosed with PCOS according to Rotterdam criteria and have serum 25(OH)D level < 20 ng/ml. The results are expected to assess the improvement of Polycystic Ovary Syndrome prognosis and the effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance.

Description:

controlled randomised double blind study to examine the Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance among Overweight Jordanian Women with Polycystic Ovary Syndrome in Irbid. comparing vitamin D with Placebo will be conducted on 60 overweight females diagnosed with PCOS according to Rotterdam criteria and have serum 25(OH)D level < 20 ng/ml. Evaluation of the effectiveness of the dose regimen considered in this study as the product SmPC which will be measured through the assessment of serum 25 (OH)D along the trial period. the expected duration of participants participation will be around 104 days divided on 6 visits. the first visit will be 7 days before the beginning of the study, the second will be at day 0 of the trial to measure the baseline, third vist at day 30, then at day 60, then at day 90 and the final visit will be after 104 days of study. The results are expected to assess the improvement of PCOS prognosis and the effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.

• Ethnic group (Caucasian).

• Healthy females aged between 18 and 49 years old.

• Overweight (BMI 25-30 kg/m2).

• Physical examination being assessed and accepted by the attending physician.

• systolic blood pressure within the normal range (90-140 mmHg).

• Diastolic blood pressure within the normal range (60-90 mmHg).

• Heart rate within the normal range (60-100 beat/min).

• Oral body temperature within the normal range (35.9 - 37.6 C?).

• Diagnosed with Polycystic ovary syndrome according to Rotterdam criteria (Rotterdam SHRE-ASRM Sponsored Polycystic ovary syndrome consensus workshop group, 2004).

• Women have serum 25(OH)D level < 20 ng/ml.

• Women have inadequate dietary intake of vitamin D (<600 IU/day or <15µg/day)

• Normal complete blood count , Liver Function enzymes test (AST, ALT) and Kidney unction tests (Urea, Creatinine).

• Able and willing to comply with all study requirements.

Exclusion Criteria:

• Female participants who is pregnant, lactating or planning pregnancy during the course of the study.

• Ethnic group non Caucasian.

• Females aged <18 or >49 years old.

• Underweight, normal body weight and obese Females.

• Females diagnosed with diabetes, hypothyroidism, hyperthyroidism, liver disease, renal dysfunction, cardiovascular diseases, androgen-secreting tumor, Cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia, and/or virilism.

• Known history or presence of food allergies or intolerance (e.g dairy products or gluten containing food), or any known condition that could interfere with the absorption, distribution, metabolism or execration of drugs.

• History of drug or alcohol abuse, smoking of 10 cigarettes or more (or equivalent) per day.

• Participants who took medications known to affect metabolic parameters, such as metformin and corticosteroid drugs, vitamin D and calcium.

• Women who have adequate dietary intake of vitamin D (600 IU/day or 15µg/day).

• Participation in another clinical or bioequivalence study within 90 days prior to the start of this study period.

• Participants with abnormal ECG.

• Participants with any abnormal laboratory results except [ 25(OH)D, Cr, Ca, phosphate, C reactive protein , triglyceride ,HDL-C, LDL-C, total cholesterol/high density lipoprotein-cholesterol ratio , fasting insulin , fasting blood glucose, oral glucose tolerance test , impaired glucose tolerance , Pr, total testosterone , sex hormone binding globulin ,parathyroid hormone and free androgen index .

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• 50.000IU Vitamin D3
50.000IU Vitamin D3 (Biodal 50.000IU ) once weekly for 3 months
• placebo
placebo coated tablet by oral route

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hayat Pharmaceutical Co. PLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progesterone Level After 3 Months	improvement of Polycystic ovary syndrome prognosis which will be measured through improving progesterone level( Regular menstruation).	3 months	Yes
Primary	Improvement of Polycystic Ovary Syndrome Prognosis Through Decreasing Hirsutism Score < 8 .	improvement of Polycystic ovary syndrome prognosis which will be measured through decreasing hirsutism score < 8 . A total of 9 body sites were assessed, the score ranging from 0 (no excessive terminal hair growth) to 36 (extensive terminal hair growth). A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).	3months	Yes
Secondary	Evaluation of the Safety of the Dose Regimen of Vitamin D3 Supplementation Which Will be Measured by Assessing the Level of PTH.	Evaluation of the safety of the dose regimen of vitamin D3 supplementation which will be measured by assessing the level of Ca, PO4 and PTH and/or reporting any adverse events through the trial period.	3 months	Yes
Secondary	The Effect of 50,000 IU Vitamin D3 Supplementation on Serum Hydroxy Vitamin D Levels.	Evaluation of the effectiveness of the dose regimen considered in this study as the product SmPC which will be measured through the assessment of serum 25 (OH)D along the trial period.	3 months	Yes
Secondary	Body Mass Index	Reduction of body mass index to be < 25-30 kg/m^2 after 3 months supplementaion of vitamin D3.	3 months	Yes
Secondary	Insulin Resistance and Improving Insulin Sensitivity After Vitamin D3 Supplementation for 3 Months.	Reduction of insulin resistance and improving insulin sensitivity measured by HOMMA method through reducing fasting insulin to be < 24 uU/ml after vitamin D3 supplementation for 3 months.	3 months	Yes
Secondary	Serum Chromium Level After Supplementation With Vitamin D3.	serum chromium level to be > 0.05 and < 0.5 ppm which will be assessed by measuring serum chromium level after supplementation of vitamin D3 for 3 months.	3 months	Yes
Secondary	Evaluation of the Safety of the Dose Regimen of Vitamin D3 Supplementation Which Will be Measured by Assessing the Level of PO4.	Evaluation of the safety of the dose regimen of vitamin D3 supplementation which will be measured by assessing the level of Ca, PO4 and PTH and/or reporting any adverse events through the trial period.	3 months	Yes
Secondary	Evaluation of the Safety of the Dose Regimen of Vitamin D3 Supplementation Which Will be Measured by Assessing the Level of Ca.	Evaluation of the safety of the dose regimen of vitamin D3 supplementation which will be measured by assessing the level of Ca, PO4 and PTH and/or reporting any adverse events through the trial period.	3 months	Yes