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

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

Sponsors

Lead Sponsor: Chinese University of Hong Kong

Source Chinese University of Hong Kong
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).

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.

Overall Status Completed
Start Date 2010-04-01
Completion Date 2015-02-01
Primary Completion Date 2014-09-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Bone mineral density 2-year time point
Secondary Outcome
Measure Time Frame
Curve severity 2-year time point
Enrollment 330
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Calcium 600mg plus Vit D 400 IU

Description: Daily supplementation with 600mg Calcium plus 400IU Vitamin D3

Arm Group Label: Ca600mg+VitD400IU

Intervention Type: Dietary Supplement

Intervention Name: Calcium 600mg plus Vit D 800 IU

Description: Daily supplementation with 600mg Calcium plus 800IU Vitamin D3

Arm Group Label: Ca600mg+VitD800IU

Intervention Type: Dietary Supplement

Intervention Name: Placebo

Description: placebo tablets

Arm Group Label: Placebo

Eligibility

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.

Gender:

Female

Minimum Age:

11 Years

Maximum Age:

14 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Tsz-ping Lam Principal Investigator Chinese University of Hong Kong
Location
Facility: Prince of Wales Hospital
Location Countries

China

Verification Date

2015-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chinese University of Hong Kong

Investigator Full Name: CHENG Chun-yiu Jack

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: Subjects in this group will take the placebo tablets

Label: Ca600mg+VitD400IU

Type: Active Comparator

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

Label: Ca600mg+VitD800IU

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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