Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)

Scoliosis Clinical Trial

Official title:

Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103115
• Other study ID #: AIS_Ca_VitD_01
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2010
• Last updated: February 2, 2015
• Start date: April 2010
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of HealthChina: The Government of the Hong Kong Special Administrative Region of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Calcium and Vit D supplementation is effective for improving low bone mass in Girls with Adolescent Idiopathic Scoliosis (AIS).

Description:

Adolescent Idiopathic Scoliosis (AIS) is a prevalent condition mainly affecting females with disease onset at early puberty. It can lead to serious health problems and is associated with low bone mass which can persist with growth. Osteopenia is found to be an important prognostic factor for curve progression in AIS. Nutritional studies indicated AIS subjects had low dietary calcium intake. Evidences suggested that Vit D insufficiency could be present in AIS. Calcium and vitamin D supplementation can therefore be a viable treatment option for low bone mass in AIS subjects. The primary objective of this prospective randomized double-blinded placebo-controlled trial is to find out whether calcium and vitamin D supplementation can improve bone mineral density (BMD) in osteopenic AIS subjects. The secondary objective of this study is to evaluate whether the supplementation is effective in controlling curve progression in AIS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• Between the ages of 11-14 (Tanner stage < IV)

• Low BMD (z-score < 0 from age-matched population mean)

• Cobb's Angle greater or equal to 15°

• Presentation at the Scoliosis Clinic without prior treatment for low bone mass.

Exclusion Criteria:

• Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or

• Patient with known endocrine and connective tissue abnormalities, or

• Patient with eating disorders or GI malabsorption disorders or

• Prior treatment for low bone mass before being recruited into the study.

• Patient currently taking medication that affects bone metabolism eg corticosterone or estrogen.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scoliosis

Intervention

Dietary Supplement:
• Calcium 600mg plus Vit D 400 IU
Daily supplementation with 600mg Calcium plus 400IU Vitamin D3
• Calcium 600mg plus Vit D 800 IU
Daily supplementation with 600mg Calcium plus 800IU Vitamin D3
• Placebo
placebo tablets

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density	To determine the effects of calcium and vitamin D intervention on improving bone mineral density of skeletally immature AIS girls with low bone mass.	2-year time point	No
Secondary	Curve severity	To determine the effects of calcium and vitamin D intervention on preventing curve progression of skeletally immature AIS girls with low bone mass.	2-year time point	No

External Links

•   Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong