Effects of Creatine Supplementation in Rett Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01147575
• Date of registration: 17/06/2010
• Prospective Registration: No
• Primary sponsor: Medical University of Vienna
• Public title: Effects of Creatine Supplementation in Rett Syndrome
• Scientific title: Effects of Creatine Supplementation in Rett Syndrome: A Randomized, Placebo-controlled Trial
• Date of first enrolment: January 2005
• Target sample size: 21
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01147575
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Michael Freilinger, MD
• Affiliation: Medical University Vienna, Dep. Pediatrics

Key inclusion & exclusion criteria

Inclusion Criteria:

- RTT Syndrome, diagnosed by current consensus criteria

Exclusion Criteria:

- taking supplements containing either folic acid or vitamin B12 or knowingly consuming
any vitamin-fortified food items



Age minimum: 3 Years
Age maximum: 24 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Rett Syndrome

Intervention(s)

Dietary Supplement: Creatine monohydrate

Dietary Supplement: Placebo

Primary Outcome(s)

Rett Syndrome Motor and Behavioral Assessment (RSMBA) [Time Frame: 6 months]

Global DNA Methylation in serum [Time Frame: 6 months]

Secondary Outcome(s)

Metabolic markers of methylation cycle [Time Frame: 6 months]

Secondary ID(s)

OENB11758

Source(s) of Monetary Support

Please refer to primary and secondary sponsors