A randomised, double blind, placebo controlled, parallel trial of folic acid and the improvement of endothelial dysfunction in obese children and adolescents

Effects of folic acid on endothelial function in obese children and adolescents

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000457549

Enrollment

Registered

2006-10-31

Start date

2004-01-02

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Worldwide obesity has increased over the last decade. Paediatric obesity is known to be an independent risk factor for adult obesity. Adolescent obesity is associated with atherosclerosis. Atherosclerosis is preceded by endothelial or blood vessel dysfunction that can be assessed by ultrasound. Endothelial dysfunction occurs in severely obese children. Early interventions to improve endothelial dysfunction in obesity, in addition to metabolic and weight control may potentially prevent atherosclerosis and heart disease. Folic acid has been proposed as one of the strategies to reduce atherosclerosis and hasn't been investigated in obesity.

Interventions

5 mg oral folic acid taken daily for 8 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

10 Years to 18 Years

Healthy volunteers

Inclusion criteria

Obese children.

Exclusion criteria

Current or recent use of Vitamin B or folic acid supplements, metformin, orlistat, Angiotensin Converting Enzyme inhibitiors, HMGCoA reductase inhibitors, and/or antihyoertensive treatment. Vitamin B12 deficiency. Smoking. Hypertension. Type 2 diabetes according to World Health Organization criteria. Endocrinological or syndromal causes of obesity.

Outcome results