Trial registered on ANZCTR


Trial ID
ACTRN12605000302651
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
5/09/2005
Date last updated
1/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of supplementation with Folinic Acid and Methionine on hypomethylation in children with Down syndrome
Scientific title
An open-label study to evaluate the effect of folinic acid and methionine in order to improve the metabolic profile of children with Down syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Down Syndrome 390 0
Condition category
Condition code
Human genetics and inherited disorders 462 462 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 children with Down syndrome and 8 healthy controls will be supplemented for four months with folinic acid (400micrograms) and methionine (400mg) per day (supplied in one capsule by Thorne Research Inc, PO Box 25, Idaho, USA 83825) Blood tests for metabolic markers on methylation and immune status will be taken on day 0 (the day before supplementation starts), day 120 (the day after supplementation finishes) and day 150 (washout).
Intervention code [1] 291 0
Treatment: Other
Comparator / control treatment
Controls: Healthy children of the same age, receiving the same treatment as the intervention group
Control group
Active

Outcomes
Primary outcome [1] 523 0
Normalisation of metabolic markers linked to hypomethylation
Timepoint [1] 523 0
Assessed after 120 days of supplementation and again 30 days later to establish the degree of wash-out
Secondary outcome [1] 1124 0
Improved immunity, learning ability and general health.
Timepoint [1] 1124 0
This is measured throughout the trial on a daily basis by the parents (on supplied diary sheets) and on a weekly basis by the researcher (phonecalls to the parents).

Eligibility
Key inclusion criteria
Children with Trisomy 21
Minimum age
5 Years
Maximum age
10 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major health problems for which they receive medication.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
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] 514 0
Commercial sector/Industry
Name [1] 514 0
Rainbow Pharmaceuticals
Address [1] 514 0
Rainbow Pahrmaceuticals
1/13 Elizabeth St
Doncaster East
VIC 3109
Country [1] 514 0
Australia
Funding source category [2] 515 0
Commercial sector/Industry
Name [2] 515 0
Thorne Research
Address [2] 515 0
25820 Highway 2 West
PO Box 25
Dover
Idaho 83825
Country [2] 515 0
United States of America
Funding source category [3] 516 0
Commercial sector/Industry
Name [3] 516 0
SC&CM
Address [3] 516 0
Southern Cross University
PO Box 157
Lismore
NSW 2480
Country [3] 516 0
Australia
Funding source category [4] 517 0
Commercial sector/Industry
Name [4] 517 0
SDS Pathology
Address [4] 517 0
10 Lyon Park Rd
North Ryde
NSW 2113
Country [4] 517 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
SDS Pathology
Address
10 Lyon Park Rd
North Ryde
NSW 2113
Country
Australia
Secondary sponsor category [1] 421 0
Commercial sector/Industry
Name [1] 421 0
Thorne Research
Address [1] 421 0
25820 Highway 2 West
PO Box 25
Dover
Idaho 83825
Country [1] 421 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1502 0
Southern Cross University
Ethics committee address [1] 1502 0
Ethics committee country [1] 1502 0
Australia
Date submitted for ethics approval [1] 1502 0
Approval date [1] 1502 0
Ethics approval number [1] 1502 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36013 0
Address 36013 0
Country 36013 0
Phone 36013 0
Fax 36013 0
Email 36013 0
Contact person for public queries
Name 9480 0
Dr. Tini Gruner
Address 9480 0
SN&CM
Southern Cross University
PO Box 157
Lismore NSW 2480
Country 9480 0
Australia
Phone 9480 0
+61 2 66203349
Fax 9480 0
Email 9480 0
tgruner@scu.edu.au
Contact person for scientific queries
Name 408 0
Sarah Harvey
Address 408 0
19 Daly Ave
Wahroonga NSW 2076
Country 408 0
Australia
Phone 408 0
+61 2 94401631 OR +61 2 94872587
Fax 408 0
Email 408 0
harve@impaq.com.au