Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers

NCT ID: NCT06241638

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-06-30

Brief Summary

The current study was conducted to evaluate the prognostic implications of vitamin B12 admission on BMI and HbA1c levels in type 2 diabetic patients treated with Dapagliflozin as a routine medication.

Detailed Description

Eighty diabetic patients were enrolled in this study; 37 females and 43 males with inclusion criteria of vitamin B12 levels less than 233 ng/ml. The participants were divided into two groups, the Dapagliflozin group (active comparator group) received only the diabetic-controlling drug Dapagliflozin 10 mg/daily orally for twelve months, whereas, vitamin B12 and Dapagliflozin group (Experimental group) received Vit. B12 supplements as methylcobalamin 500 µg orally once daily with Dapagliflozin 10 mg/daily orally for twelve months. Glycemic control was measured by monitoring levels of HbA1c and Vitamin B12 in the participant's blood four times at time intervals of three months during the study period. Additionally, the weight measurements were recorded during the study period at time intervals of three months and BMI was calculated. The data obtained was treated by statistical analysis using SPSS software (version 20) for the significant correlation of the independent variables of the study groups after vitamin B12 supplementation.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Dapagliflozin group

Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months

Group Type: ACTIVE_COMPARATOR

Dapagliflozin 10mg Tab

Intervention Type: DRUG

The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group.

The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.

Vitamin B12 and Dapagliflozin group

Vitamin B12 and Dapagliflozin group received orally Vit. B12 supplements methylcobalamin 500 µg once daily with their usual anti-diabetic therapy Dapagliflozin 10 mg/daily for twelve months.

Group Type: EXPERIMENTAL

Vitamin B12 0.5 MG/ACTUAT

Intervention Type: DRUG

The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group.

The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.

Dapagliflozin 10mg Tab

Intervention Type: DRUG

The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group.

The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.

Interventions

Vitamin B12 0.5 MG/ACTUAT

The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group.

The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.

Intervention Type: DRUG

Dapagliflozin 10mg Tab

The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group.

The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diabetic patient treated with Dapagliflozin

Exclusion Criteria

• The levels of Vitamin B12 more than 200 ng/ml

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Balqa Applied University

OTHER

Sponsor Role: lead

Responsible Party

Walid Salem Aburayyan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Walid Aburayyan

Salt, , Jordan

Countries

Jordan

References

Aburayyan W, Zakaraya Z, Hamad M, Majali IS, Abu Dayyih W, Seder N, Alkhadeir H, Khaleel A. Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers, Combined with Dapagliflozin as Type 2 Diabetes Mellitus Routine Treatment: A Controlled Randomized, Double-blind Trial. Iran J Med Sci. 2025 May 1;50(5):324-333. doi: 10.30476/ijms.2024.101606.3423. eCollection 2025 May.

Reference Type: DERIVED

PMID: 40433181 (View on PubMed)

Other Identifiers

SREC-2022/783

Identifier Type: -

Identifier Source: org_study_id