The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 9 May 2022
• Main ID: NCT05352373
• Date of registration: 15/04/2022
• Prospective Registration: No
• Primary sponsor: Baylor College of Medicine
• Public title: The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
• Scientific title: The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
• Date of first enrolment: March 1, 2008
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT05352373
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Contacts

• Name: Kathleen J Motil, MD, PHD
• Affiliation: Baylor College of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria

- clinical diagnosis of Rett syndrome

Exclusion Criteria

- parathyroid disease

- renal disease



Age minimum: 5 Years
Age maximum: 30 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Rett Syndrome

Intervention(s)

Dietary Supplement: calcium

Dietary Supplement: placebo

Primary Outcome(s)

Bone mineral content (BMC) [Time Frame: change from baseline to 1 year thereafter]

Bone mineral density (BMD) [Time Frame: change from baseline to 1 year thereafter]

Secondary Outcome(s)

C-telopeptide [Time Frame: change from baseline to 1 year thereafter]

Calcium/creatinine ratio [Time Frame: change from baseline to 1 year thereafter]

Bone alkaline phosphatase [Time Frame: change from baseline to 1 year thereafter]

Osteocalcin [Time Frame: change from baseline to 1 year thereafter]

Secondary ID(s)

H-19205

Source(s) of Monetary Support

Please refer to primary and secondary sponsors