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Trial registered on ANZCTR


Registration number
ACTRN12606000457549
Ethics application status
Approved
Date submitted
30/10/2006
Date registered
31/10/2006
Date last updated
31/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double blind, placebo controlled, parallel trial of folic acid and the improvement of endothelial dysfunction in obese children and adolescents
Scientific title
Effects of folic acid on endothelial function in obese children and adolescents
Secondary ID [1] 314 0
Children, Youth and Women's Health Service (CYWHS) Ethics Committee: REC 1513
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obese children and adolescents 1432 0
Condition category
Condition code
Diet and Nutrition 1528 1528 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5 mg oral folic acid taken daily for 8 weeks
Intervention code [1] 1422 0
Prevention
Comparator / control treatment
Placebo tablets taken orally once a day for 8 weeks. Placebo tablets contain: Lactose (58.842 mg), Cellulose (6.538 mg), Hydrogenated Vegetable Oil (2.100 mg), Magnesium Stearate (0.350 mg), Quinoline Yellow Lake (2.009 mg), Sunset Yellow Lake (0.154 mg), Brilliant Blue Lake (0.007 mg)
Control group
Placebo

Outcomes
Primary outcome [1] 2112 0
Endothelial function measured by flow mediated dilatation
Timepoint [1] 2112 0
At -8, 0, 8 and 16 weeks. Two measurements pre and 2 measurements post treatment.
Secondary outcome [1] 3651 0
Folate and homocysteine levels
Timepoint [1] 3651 0
Also measured at -8, 0, 8 and 16 weeks.Two measurements pre and two measurements post treatment.
Secondary outcome [2] 3652 0
Glyceryl trinitrate mediated dilatation
Timepoint [2] 3652 0
Also measured at -8, 0, 8 and 16 weeks.Two measurements pre and two measurements post treatment.

Eligibility
Key inclusion criteria
Obese children.
Minimum age
10 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was done by pharmacy using numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using Fisher table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects and Assessor
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1666 0
Charities/Societies/Foundations
Name [1] 1666 0
Women's and Chidlren's Research Foundation
Address [1] 1666 0
Country [1] 1666 0
Australia
Funding source category [2] 1667 0
University
Name [2] 1667 0
IPRS and University of Adelaide Scholarship
Address [2] 1667 0
Country [2] 1667 0
Australia
Primary sponsor type
Government body
Name
Children, Youth and Women's Health Service
Address
Country
Australia
Secondary sponsor category [1] 1470 0
University
Name [1] 1470 0
University of Adelaide
Address [1] 1470 0
Country [1] 1470 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3108 0
Children, Youth and Women's Health Service
Ethics committee address [1] 3108 0
Ethics committee country [1] 3108 0
Australia
Date submitted for ethics approval [1] 3108 0
Approval date [1] 3108 0
21/11/2003
Ethics approval number [1] 3108 0
1513/10/2006

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27356 0
Address 27356 0
Country 27356 0
Phone 27356 0
Fax 27356 0
Email 27356 0
Contact person for public queries
Name 10611 0
Alexia Sophie Peña
Address 10611 0
C/O Endocrine Department
Children, Youth and Women's Health Service
72 King William Road
North Adelaide SA 5006
Country 10611 0
Australia
Phone 10611 0
+61 8 81616402
Fax 10611 0
+61 8 81617759
Email 10611 0
alexia.pena@adelaide.edu.au
Contact person for scientific queries
Name 1539 0
Jennifer Couper
Address 1539 0
C/O Endocrine Department
Children, Youth and Women's Health Service
72 King William Road
North Adelaide SA 5006
Country 1539 0
Australia
Phone 1539 0
+61 8 81616402
Fax 1539 0
+61 8 81617759
Email 1539 0
jennifer.couper@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary