Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction

What Was Tested

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

Scoliosis is a condition in which there is curvature of the spine occurring in the lateral plane.

It occurs in structural forms, characterized by a fixed curve, and "functional" forms, characterized by a flexible or correctable curve.

It had two arms (groups): control group (placebo comparator) and ultra-short-term treatment (experimental).

The registry classes the interventions as drug.

More on the Plan

Patient's vital signs will be monitored during and at least 15 min after drug application.

Treatment will be given one day before the operation Measurements: 1.

The number of RBC transfusions during the first 7 days. 3.

Perioperative course of Hb, (reticulocyte count, reticulocyte Hb content). 4.

Who Took Part

44 actual participants took part.

It was open to people of any sex aged from 13 years up to 45 years.

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

Examples of who could join: Patients with idiopathic adolescent scoliosis.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: impairments, diseases (renal \&/ hepatic) or language problems which do not allow the patient to fully understand the consequences of study participation; known allergy against iron - carboxymaltose.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

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

In this single-blind Cyanocobalamin (Vitamin B12) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2023-09-01 with completion listed for 2024-09-15.

It ran at 1 site in Egypt.

Its stated primary purpose is other.

What Was Measured

Primary outcome: percentage of patients not required blood transfusion (time frame: up to 7 days postoperative).

It also tracked 7 secondary outcomes, for example the length in I.C.U, the incidence of acute kidney injury, incidence of infections requiring antibiotic treatment, perioperative hemoglobin, perioperative platelet and perioperative leucocyte counts.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 44 people with anemia.

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, Anemia research.