Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Impact of Vitamin D Supplementation on Cardiometabolic Status and Androgen Profile in Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117750
Recruitment Status : Completed
First Posted : October 7, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Nearmeen M.Rashad, Zagazig University

Brief Summary:
Polycystic ovary syndrome (PCOS) is a heterogeneous disorder of reproductive, endocrine and metabolic functions. Vitamin D has an influence on metabolic and reproductive functions. This study was designed to explore the levels of free 25 hydroxy cholecalciferol [25(OH) D] in PCOS patients. We also aimed to clarify the impact of vitamin D supplementation on cardiometabolic status, androgen profile and clinical features of PCOS.

Condition or disease Intervention/treatment Phase
Evaluations, Diagnostic Self Treatment Adherence Dietary Supplement: cholecalciferol (vit D3) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Impact of Vitamin D Supplementation on the Cardiometabolic Status and Androgen Profile in Women With Polycystic Ovary Syndrome: Placebo-Controlled Clinical Trial
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: intervention group
55 female patients with PCO
Dietary Supplement: cholecalciferol (vit D3)
42,000 IU oral vitamin D per week and 500 mg calcium carbonate
Other Name: calcium carbonate

Placebo Comparator: non -intervention group
40 female patients with PCO and 50 healthy women matched to PCOS women as regard age and ethnic origin.
Dietary Supplement: cholecalciferol (vit D3)
42,000 IU oral vitamin D per week and 500 mg calcium carbonate
Other Name: calcium carbonate




Primary Outcome Measures :
  1. change of lipid profiles in intervention arm of PCOS patients who received vitamin d supplementation [ Time Frame: 12 weeks ]
    change of LDL (mg/dl), TG (mg/dl) TG (mg/dl) ,(mg/dl)

  2. Improvement of fertility ;ovarian size [ Time Frame: 12 weeks ]
    Ovarian volume cm were evaluated by transvaginal ultrasound

  3. change of vitamin D deficiency [ Time Frame: 12 weeks ]
    Serum concentrations of 25(OH)-D( ng/ml )

  4. Change of androgenic levels in intervention arm of PCOS patients who received vitamin d [ Time Frame: 12 weeks ]
    total testosterone (ng/mL),

  5. Change of inflammatory markers in intervention arm of PCOS patients who received vitamin d [ Time Frame: 12 weeks ]
    hs-CRP (µg/ml)

  6. change of BMI [ Time Frame: 12 weeks ]
    weight in kilograms, height in meters

  7. change of fertility , antral follicular count [ Time Frame: 12 weeks ]
    antral follicular count were evaluated by transvaginal ultrasound



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 33 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female patient with pco
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. women with PCO. The diagnosis of PCOS was based on the 2004 revised Rotterdam criteria
  2. women must be able to swallow tablets

Exclusion Criteria:

  1. a history of hyperandrogenic states (such as nonclassic congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, 21-hydroxylase deficiency, or hyperprolactinemia)
  2. DM3-hypertension
  3. liver diseases
  4. kidney diseases
  5. Insulin-dependent diabetes
  6. thyroid diseases.
  7. women received non-steroidal anti-inflammatory drugs , multivitamins, and hormone replacement therapy.

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): NCT04117750


Locations
Layout table for location information
Egypt
Zagazig University
Zagazig, El-Shakia, Egypt, 44519
Sponsors and Collaborators
Zagazig University

Publications:

Layout table for additonal information
Responsible Party: Nearmeen M.Rashad, ass.professor of internal medicine, Zagazig University
ClinicalTrials.gov Identifier: NCT04117750    
Other Study ID Numbers: vitamin D and PCO
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: participants data without names
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: after the publication of the study

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nearmeen M.Rashad, Zagazig University:
PCOS
VD supplementation
androgen level
cardio metabolic
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Calcium Carbonate
Calcium
Androgens
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents