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

Phase 3

Completed

• Conditions: Scoliosis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Calcium 600mg plus Vit D 400 IU; Dietary Supplement: Calcium 600mg plus Vit D 800 IU

• Registration Number: NCT01103115
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-05
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Primary Completion: 2014-09
• Status Verified: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 330

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects in this group will take the placebo tablets
Ca600mg+VitD400IU	Calcium 600mg plus Vit D 400 IU	subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3
Ca600mg+VitD800IU	Calcium 600mg plus Vit D 800 IU	subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3

Primary Outcome Measures

Name	Time	Method
Bone mineral density	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

Name	Time	Method
Curve severity	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.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong SAR, China