Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).

Type 1 diabetes can complicate to peripheral neuropathy due to preferential involvement of small unmyelinated nerve fibers (pain and temperature sensation) followed by myelinated nerve fibers (vibration and proprioception).

The clinical form of peripheral neuropathy is rare in childhood and pathophysiological changes begin during childhood and accelerate in puberty.

It had three arms (groups): Arm 1: Only vitamin B12 supplements (active comparator), Arm 2: Vitamin B12 and oral iron supplements (active comparator) and Arm 3: Vitamin B12 and vitamin D3 (active comparator).

The registry classes the interventions as dietary supplement.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 10 years up to 22 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Children/ parents/ youth willing to participate in the study with an informed consent/ assent. Children/ youth Age \> 10 years. Diabetes duration \> 2 years. Diagnosed with type 1 diabetes.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: age \< 10 years; diabetes duration \< 2 years; children/ youth receiving vitamin b12, vitamin d and/or oral iron supplements.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-02-08 with completion listed for 2025-02-08.

It ran at 1 site in India.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Nerve conduction velocity (time frame: 6 months). Serum vitamin B12, serum ferritin, serum vitamin D3 (time frame: 6 months).

It also tracked 3 secondary outcomes, for example Dynamic muscle function, Dynamic muscle function and Glycemic control (HbA1c).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 120 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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