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

Baylor College of Medicine

Status: Completed

Conditions: Rett Syndrome

Treatments: Dietary Supplement: placebo; Dietary Supplement: calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT05352373

H-19205

Details and patient eligibility

About

Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome

Full description

Objective: The investigators conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of oral calcium supplementation for the treatment of bone mineral deficits in individuals with Rett syndrome (RTT).

Methods: The investigators measured total body bone mineral content (BMC) and bone mineral density (BMD) by dual-energy x-ray absorptiometry and biomarkers of bone turnover by clinical laboratory techniques before and one year after oral calcium or placebo supplementation in 32 pre- and post-pubertal girls and young women with RTT. The calcium supplement was calculated to provide a twofold increase in the recommended dietary allowance of calcium for age.

Enrollment: 32 patients

Sex: Female

Ages: 5 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• clinical diagnosis of Rett syndrome

Exclusion Criteria

• parathyroid disease
• renal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Rett Active Supplement

Active Comparator group

Description:

Females with clinical diagnosis of Rett syndrome treated orally daily with calcium carbonate, dose based on Dietary Reference Intake for age, for one year

Treatment:

Dietary Supplement: calcium

Rett Placebo Supplement

Placebo Comparator group

Description:

Females with clinical diagnosis of Rett syndrome treated orally daily with sodium bicarbonate, dose based on equivalent weight for active supplement for age, for one year

Treatment:

Dietary Supplement: placebo