Study of vitamin K2-7(MK-7)levels in patients with tingling and numbness due to diabetes and/or vitamin B12 deficiency

To measure serum Vitamin K2-7 levels in patients with peripheral neuropathy due to type 2 diabetes mellitus and/ or vitamin B12 deficiency supplemented with Vitamin K2-7

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/06/019548

Enrollment

Registered

2019-06-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications Health Condition 2: D519- Vitamin B12 deficiency anemia, unspecified

Interventions

Intervention1: Vitamin K2-7 Capsules: Each capsule of 100 mcg to be given two times in a day orally after food for 8 weeks Control Intervention1: Placebo capsules: Each capsule identical to Vitamin K2

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 65 who are suffering from type 2 diabetes mellitus and/ or vitamin B12 deficiency. 2. Symptomatic diagnosis of neuropathy ( >4 on VAS score). 3. Willing to give informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who are suffering from any other systemic illness other than type 2 diabetes mellitus or vitamin B12 deficiency. 2. Patients who are on corticosteroids and oral contraceptives 3. Patients with seropositive status. 4. Pregnancy 5. Patients Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study. 6. Patients who are on coumarin analogues 7. Patients who are on Quinine Hydrochloride 8. History of alcohol. substance abuse or alcoholism, within the previous one year

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to compare the activity and tolerability of Vitamin K2-7 with placebo in patients with peripheral neuropathy and to measure levels of vitamin K2-7 in serumTimepoint: 0 day, 2nd week, 4th week, 8th week, 12th week	—

Secondary

Measure	Time frame
Safety and tolerability; clinical and metabolic variables.Timepoint: 0 day, 2nd week, 4th week, 8th week, 12th week	—

Countries

India

Contacts

Public ContactDr Shashank Jadhav

Synergia Life Sciences Pvt Ltd

yogesh_dound@yahoo.com0224055607

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026