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

• ClinicalTrials.gov Identifier: NCT01103115
• Recruitment Status: Completed
• First Posted: April 14, 2010
• Last Update Posted: February 4, 2015
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): CHENG Chun-yiu Jack, Chinese University of Hong Kong

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Scoliosis	Dietary Supplement: Calcium 600mg plus Vit D 400 IU; Dietary Supplement: Calcium 600mg plus Vit D 800 IU; Dietary Supplement: Placebo	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?
• Study Start Date: April 2010
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Subjects in this group will take the placebo tablets	Dietary Supplement: Placebo; placebo tablets
Active Comparator: Ca600mg+VitD400IU; subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3	Dietary Supplement: Calcium 600mg plus Vit D 400 IU; Daily supplementation with 600mg Calcium plus 400IU Vitamin D3
Active Comparator: Ca600mg+VitD800IU; subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3	Dietary Supplement: Calcium 600mg plus Vit D 800 IU; Daily supplementation with 600mg Calcium plus 800IU Vitamin D3

Outcome Measures

Primary Outcome Measures :

1. Bone mineral density [ Time Frame: 2-year time point ]
   To determine the effects of calcium and vitamin D intervention on improving bone mineral density of skeletally immature AIS girls with low bone mass.

Secondary Outcome Measures :

1. Curve severity [ Time Frame: 2-year time point ]
   To determine the effects of calcium and vitamin D intervention on preventing curve progression of skeletally immature AIS girls with low bone mass.

Eligibility Criteria

• Ages Eligible for Study: 11 Years to 14 Years (Child)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China

Prince of Wales Hospital

Hong Kong SAR, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

• Principal Investigator: Tsz-ping Lam; Chinese University of Hong Kong

More Information

Additional Information:

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

• Responsible Party: CHENG Chun-yiu Jack, Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT01103115
• Other Study ID Numbers: AIS_Ca_VitD_01
• First Posted: April 14, 2010
• Last Update Posted: February 4, 2015
• Last Verified: February 2015

Keywords provided by CHENG Chun-yiu Jack, Chinese University of Hong Kong:

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

Additional relevant MeSH terms:

Scoliosis; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Calcium, Dietary; Vitamin D; Calcium Carbonate; Calcium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Vitamins; Micronutrients; Nutrients; Growth Substances; Antacids; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents