The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients
1 other identifier
interventional
106
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Oct 2019
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2019
CompletedStudy Start
First participant enrolled
October 27, 2019
CompletedFirst Posted
Study publicly available on registry
February 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedJanuary 25, 2023
January 1, 2023
2.3 years
October 17, 2019
January 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Homeostasis model assessment of insulin resistance (HOMA-IR)
24 weeks
Study Arms (2)
Vitamin K 1mg
EXPERIMENTALControl
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Al Aini Hospital
Cairo, 11562, Egypt
Related Publications (1)
Ali AM, Abbassi MM, Sabry NA, Fawzi M, Mousa S. The effect of vitamin K4 supplementation on insulin resistance in individuals with type 2 diabetes: a double-blind randomised placebo-controlled clinical trial. Eur J Nutr. 2023 Dec;62(8):3241-3249. doi: 10.1007/s00394-023-03215-8. Epub 2023 Aug 8.
PMID: 37552330DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
October 17, 2019
First Posted
February 26, 2020
Study Start
October 27, 2019
Primary Completion
March 1, 2022
Study Completion
May 30, 2022
Last Updated
January 25, 2023
Record last verified: 2023-01