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

NCT01103115 | Completed Phase 3

• 1 other identifier: AIS_Ca_VitD_01
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Scoliosis

Keywords

Adolescent Idiopathic Scoliosis; AIS; low bone mass; osteopenia; bone health; bone density

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Curve severity

  2-year time point

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects in this group will take the placebo tablets

Dietary Supplement: Placebo

Ca600mg+VitD400IU

ACTIVE COMPARATOR

subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3

Dietary Supplement: Calcium 600mg plus Vit D 400 IU

Ca600mg+VitD800IU

ACTIVE COMPARATOR

subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3

Dietary Supplement: Calcium 600mg plus Vit D 800 IU

Interventions

Calcium 600mg plus Vit D 400 IU DIETARY_SUPPLEMENT

Daily supplementation with 600mg Calcium plus 400IU Vitamin D3

Ca600mg+VitD400IU

Calcium 600mg plus Vit D 800 IU DIETARY_SUPPLEMENT

Daily supplementation with 600mg Calcium plus 800IU Vitamin D3

Ca600mg+VitD800IU

Placebo DIETARY_SUPPLEMENT

placebo tablets

Placebo

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong SAR, China

Location

Related Links

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

MeSH Terms

Conditions

Scoliosis; Bone Diseases, Metabolic

Interventions

Calcium

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Tsz-ping Lam

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 14, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

CN (1)