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CompletedNCT04285450Updated Jan 25, 2023

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

An interventional study of Vitamin K and Placebo in Diabetes Mellitus, Type 2, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 106 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    Vitamin K 1mg

    Dietary Supplement: Vitamin K

  • Placebo comparator
    Control

    Other: Placebo

Interventions

  • Dietary supplementVitamin K

    1mg

  • OtherPlacebo

    Lactose

06

What researchers measure

Primary outcomes

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

    Time frame: 24 weeks

07

Study locations

1 site
  • Kasr Al Aini Hospital
    Cairo, 11562, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04285450
Lead sponsor
Cairo University
Responsible party
Amani Mohamed (Assistant Lecturer, Cairo University) — Principal investigator
First posted
Feb 26, 2020
Start date
Oct 27, 2019
Primary completion
Mar 1, 2022
Completion
May 30, 2022
Last update
Jan 25, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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