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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285450
• Other study ID #: CL2182
• Status: Completed
• Phase: N/A
• Start date: October 27, 2019
• Est. completion date: May 30, 2022

Study information

• Verified date: January 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 30, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Vitamin K
1mg

Other:
• Placebo
Lactose

Locations

Country	Name	City	State
Egypt	Kasr Al Aini Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostasis model assessment of insulin resistance (HOMA-IR)		24 weeks