Effect of supplementation with Folinic Acid and Methionine on hypomethylation in children with Down syndrome

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

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000302651

Enrollment

Registered

2005-09-05

Start date

2005-08-01

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

Interventions

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).

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to 10 Years

Healthy volunteers

Inclusion criteria

Children with Trisomy 21

Exclusion criteria

Major health problems for which they receive medication.

Outcome results