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Completed

NCT Number: NCT04285450

The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients

The aim of this study is to examine the possible clinical effects associated with vitamin K supplementation on the glycemic control, insulin sensitivity and lipid profile of type II diabetic patients.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Al Aini Hospital

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients 21-65 years old diagnosed with Type II diabetes.
  • Fasting blood glucose concentration ≥ 126 mg/dL .
  • Normal liver Function tests defined as ALT levels up to 33 U/L for males and up to 25 U/L for females, Albumin levels ≥ 3.5 g/dL, Bilirubin up to 1.1 mg/dL .
  • Normal clotting function defined as defined by INR.
  • Normal kidney function defined as serum creatinine values up to 1.3 mg/dL.

Exclusion criteria

  • Type I diabetic patients.
  • Use of supplements with potential effect on vitamin K level namely supplements containing vitamin K, co-enzyme Q10 or vitamin E > 400 IU .
  • Patients requiring anti-coagulant therapy including patients with prosthetic valves, mitral tissues, DVT, PE, atrial fibrillation and valvular heart disease.
  • Patient with history of coagulation, MI, stroke and embolization.
  • Pregnant or breast feeding women.
  • Being on hormonal therapy or receiving contraceptive pills.
  • Patients treated with glucocorticoids, thiazide diuretics, and atypical antipsychotics.
  • Patients on cholestyramine, antibiotics and coumarins.
  • Patients on lipid lowering agents.
  • Known intestinal malabsorption syndrome, cholestasis or steatorrhea.
  • Smokers.

Treatment and study plan

Vitamin K

Dietary Supplement

1mg

Placebo

Other

Lactose

Primary outcomes

  1. Homeostasis model assessment of insulin resistance (HOMA-IR)

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2020
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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