ClinicalTrials.gg
RecruitingNCT05375630SARK2Updated Jul 28, 2023

Vitamin K2 and Muscle Weakness in Type 2 Diabetes

An interventional study of Placebo and Vitamin K2 in Diabete Type 2, sponsored by Dasman Diabetes Institute. Recruiting at 1 site in Kuwait. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-07-28.

Sponsored by Dasman Diabetes Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Mar 2022; still recruiting 4 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

The aim of the current study is to determine the effects of vitamin K2 supplementation on muscle size and function in adults with muscle weakness and type 2 diabetes.

02

Conditions studied

  • Diabete Type 2
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Dasman Diabetes Institute is the lead sponsor of 31 studies on the registry; 14 are open to participants now.

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

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Physician confirmed type 2 diabetes.
  • Age >/= 40 years
  • No changes in anti-diabetic medication in the last 3 months.
  • Muscle weakness (grip strength \<27kg and females \<16kg)

Exclusion criteria

Exclusion Criteria:

  • of 45 or higher
  • BP of 160/100mmHg or higher
  • Cancer or cancer that has been in remission \<5 years
  • Any medical condition that prevents participants from exercising safely
  • On anticoagulant therapy
  • Currently consuming vitamin K2 supplements
  • Current smoker
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    micro-crystalline cellulose placebo (one 380 mg tablet per day)

    Dietary Supplement: Placebo

  • Active comparator
    Vitamin K2

    micro-crystalline cellulose (one 380 mg tablet per day) where vitamin K2 (K2VITAL® 0.2% DELTA powder) is mixed into the formulation to a final vitamin K2 concentration of 240 μg/tablet

    Dietary Supplement: Vitamin K2

Interventions

  • Dietary supplementPlacebo

    Placebo

  • Dietary supplementVitamin K2

    Vitamin K2

06

What researchers measure

Primary outcomes

  1. Grip Strength

    Change in Grip Strength

    Time frame: Baseline to one year

Secondary outcomes

  1. SPPB

    Change in Short Performance Physical Battery Test

    Time frame: Baseline to one year

  2. HbA1c

    Change in glycated haemoglobin

    Time frame: Baseline to one year

  3. Blood Pressure

    Change in blood pressure

    Time frame: Baseline to one year

  4. Body Mass

    Change in body mass

    Time frame: Baseline to one year

  5. Lean Mass

    Change in lean mass

    Time frame: Baseline to one year

  6. Body Fat

    Change in body fat

    Time frame: Baseline to one year

  7. BMC

    Change in bone mineral content

    Time frame: Baseline to one year

  8. BMD

    Change in bone mineral density

    Time frame: Baseline to one year

  9. Vitamin K status

    Change in vitamin K status

    Time frame: Baseline to one year

07

Study locations

1 of 1 sites recruiting
  • Dasman Diabetes Institute
    Kuwait City, 15462, Kuwait
    Recruiting
    • Ebaa AlOZairi · Contact
    • Ebaa AlOzairi · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05375630
Lead sponsor
Dasman Diabetes Institute
Collaborators
Kappa Bioscience
Responsible party
Dr. Ebaa Al Ozairi (Chief Medical Officer, Dasman Diabetes Institute) — Principal investigator
First posted
May 16, 2022
Start date
Mar 21, 2022
Primary completion
Oct 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Jul 28, 2023

Study contacts

Stuart Gray
Contact
stuart.gray@glasgow.ac.uk
01413302569
Ebaa AlOzairi
principal investigator · Dasman Diabetes Institute

Oversight

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

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Studies of the drug tested here: Vitamin K 2

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