Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 2) is built around Insulin (regular human).

It had two arms (groups): Group I (experimental) and Group II (active comparator).

This group of patients will receive their standard insulin treatment only.

The registry classes the interventions as dietary supplement and drug.

Who Took Part

49 actual participants took part.

It was open to people of any sex aged from 8 years up to 18 years.

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

Examples of who could join: Age: patients from 8 to 18 years old. Outpatient with at least 1 year history of type 1 diabetes mellitus. Approval to participate and give informed consent.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism; preexisting cardiovascular disease or hypertension; chronic kidney disease or chronic liver disease.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2017-03-19 with completion listed for 2018-01-20.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): change in soluble interacellular adhesion molecule level (time frame: three months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 49 people.

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

More context: the Insulin (regular human) compound page, all human trials.