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

NCT04117750 | Completed DMC

• 1 other identifier: vitamin D and PCO
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Evaluations, Diagnostic Self; Treatment Adherence

Keywords

PCOS; VD supplementation; androgen level; cardio metabolic

Outcome Measures

Primary Outcomes (7)

• change of lipid profiles in intervention arm of PCOS patients who received vitamin d supplementation

  change of LDL (mg/dl), TG (mg/dl) TG (mg/dl) ,(mg/dl)

  12 weeks

• Improvement of fertility ;ovarian size

  Ovarian volume cm were evaluated by transvaginal ultrasound

  12 weeks

• change of vitamin D deficiency

  Serum concentrations of 25(OH)-D( ng/ml )

  12 weeks

• Change of androgenic levels in intervention arm of PCOS patients who received vitamin d

  total testosterone (ng/mL),

  12 weeks

• Change of inflammatory markers in intervention arm of PCOS patients who received vitamin d

  hs-CRP (µg/ml)

  12 weeks

• change of BMI

  weight in kilograms, height in meters

  12 weeks

• change of fertility , antral follicular count

  antral follicular count were evaluated by transvaginal ultrasound

  12 weeks

Study Arms (2)

intervention group

ACTIVE COMPARATOR

55 female patients with PCO

Dietary Supplement: cholecalciferol (vit D3)

non -intervention group

PLACEBO COMPARATOR

40 female patients with PCO and 50 healthy women matched to PCOS women as regard age and ethnic origin.

Dietary Supplement: cholecalciferol (vit D3)

Interventions

cholecalciferol (vit D3) DIETARY_SUPPLEMENT

42,000 IU oral vitamin D per week and 500 mg calcium carbonate

Also known as: calcium carbonate

intervention group; non -intervention group

Eligibility Criteria

• Age: 20 Years - 33 Years
• Gender Eligibility Details: female patient with pco
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, El-Shakia, 44519, Egypt

Location

Related Publications (16)

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• Kakarala RR, Chandana SR, Harris SS, Kocharla LP, Dvorin E. Prevalence of vitamin D deficiency in uninsured women. J Gen Intern Med. 2007 Aug;22(8):1180-3. doi: 10.1007/s11606-007-0245-x. Epub 2007 Jun 2.

  PMID: 17546478 BACKGROUND

• Hahn S, Haselhorst U, Tan S, Quadbeck B, Schmidt M, Roesler S, Kimmig R, Mann K, Janssen OE. Low serum 25-hydroxyvitamin D concentrations are associated with insulin resistance and obesity in women with polycystic ovary syndrome. Exp Clin Endocrinol Diabetes. 2006 Nov;114(10):577-83. doi: 10.1055/s-2006-948308.

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  PMID: 20660450 BACKGROUND

• Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.

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  PMID: 18261694 BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

Cholecalciferol; Calcium Carbonate

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ass.professor of internal medicine

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: October 7, 2019
• Study Start: November 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after the publication of the study

Locations

EG (1)