Efficacy of two doses( 500mcg and 1000mcg) of Vitamin B12 supplementation on glycemic control in poorly controlled type 2 diabetic patients with hyperhomocysteinemia

Efficacy of two doses(500mcg and 1000mcg) of Vitamin B12 supplementation on glycaemic control in poorly controlled type 2 Diabetic patients with hyperhomocysteinemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044720

Enrollment

106

Registered

2022-08-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Vitamin B12( methlycobalamine): Vitamin B12 500mcg orally once daily at bed time for 8 weeks, Control Intervention1: Vitamin B12( methycobalamine): Vitamin B12 1000 mcg given orally onc

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male,non-lactating female above the age of 30 years, diagnosed with type 2 diabetes mellitus and who are poorly controlled 2. HBA1c > 7% 3.Vitamin B12 levels 4. Homocysteine levels >15 mcgmol/L

Exclusion criteria

Exclusion criteria: 1. Patients who were on non-allopathic forms of treatment for glycemic control 2.Patients receiving insulin 3. Patients having diagnosed of renal function abnormalities with eGFR 4.Patients diagnosed of liver function abnormalities 5. Patients with insulin dependent diabetes mellitus, severe and complicated diabetes, pregnancy and lactating mother Anaemic patients with HBA1c 6.Patients on vitamin B12 supplementation 7. Patients on drugs affecting glucose metabolism such as fluoroquinolones, phenytoin Patients who presented with alcoholism, gastrectomy, gastric by pass surgery, pancreatic insufficiency, malabsorption syndromes chronic giardiasis or surgery involving small intestine.

Design outcomes

Primary

Measure	Time frame
Mean changes in the HBA1c level from the baseline value at the end of 8 weeks therapyTimepoint: First visit (baseline, 0 weeks) Second visit( 8th week) Third visit ( 6th month)	—

Secondary

Measure	Time frame
1.Mean changes in the homocysteine level from the baseline value at the end of 8 weeks therapy 2. Mean changes in the fasting blood glucose level from baseline at the end of 8 weeks therapy 3.Mean changes in the plasma insulin level from the baseline value at the end of 8 weeks therapy 4. Mean changes in the parameters of lipid profile levels from the baseline value at the end of 8 weeks therapy 5. Mean changes in the HBA1c level at the end of 6 month follow up 6. Mean changes in the fasting blood glucose level at the end of 6 month follow upTimepoint: First visit( baseline, 0 weeks) Second visit( 8th week Third visit ( 6th month)	—

Measure

Time frame

1.Mean changes in the homocysteine level from the baseline value at the end of 8 weeks therapy 2. Mean changes in the fasting blood glucose level from baseline at the end of 8 weeks therapy 3.Mean changes in the plasma insulin level from the baseline value at the end of 8 weeks therapy 4. Mean changes in the parameters of lipid profile levels from the baseline value at the end of 8 weeks therapy 5. Mean changes in the HBA1c level at the end of 6 month follow up 6. Mean changes in the fasting blood glucose level at the end of 6 month follow upTimepoint: First visit( baseline, 0 weeks) Second visit( 8th week Third visit ( 6th month)

—

Countries

India

Contacts

Public ContactDr Prachi Arunima

All India Institute of Medical Sciences, Raipur

drynkeche@gmail.com8818882119

Outcome results

None listed

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