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Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers

Plain-language guide to NCT06241638: not phased randomized trial of Cyanocobalamin (Vitamin B12), 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06241638
Phase
not phased
Status
completed
Start
2022-07-01
Completion (planned or actual)
2023-06-30
Participants
80 (actual)
Design
randomized, single-blind, basic_science
Conditions studied
Diabetes Mellitus
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12).

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.

It had two arms (groups): Dapagliflozin group (active comparator) and Vitamin B12 and Dapagliflozin group (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 80 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Diabetic patient treated with Dapagliflozin.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: the levels of vitamin b12 more than 200 ng/ml.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Cyanocobalamin (Vitamin B12) was given.

Those kept unaware of assignments: participant.

It started in 2022-07-01 with completion listed for 2023-06-30.

It ran at 1 site in Jordan.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: HbA1c in the two groups (time frame: One year).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.

Our Notes on the Compound

Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.