Diabetes Mellitus, Type 2NCT04285450
The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients
A study testing Vitamin K in people with Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vitamin K
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Oct 2019to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vitamin K, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin KDietary supplement
1mg
PlaceboOther
Lactose
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K 1mg | Experimental | Not described Receives: Dietary Supplement: Vitamin K |
| Control | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start27 Oct 2019
- Primary completion1 Mar 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285450
- Sponsor's protocol ID
- CL2182
- Status last verified
- Jan 2023
- First submitted
- 17 Oct 2019
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37552330
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT04285450
- Acronym / sponsor ID
- CL2182
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Oct 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin K 1mg | Experimental | Dietary Supplement: Vitamin K |
| Control | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K1mg | Dietary supplement | Vitamin K 1mg |
| PlaceboLactose | Other | Control |
Primary outcome
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 37552330Ali 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K in people with Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostasis model assessment of insulin resistance (HOMA-IR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04285450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.