NCT01103115

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?

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Female
• Age: 11 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scoliosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Calcium 600mg plus Vit D 400 IU	Daily supplementation with 600mg Calcium plus 400IU Vitamin D3
DIETARY_SUPPLEMENT	Calcium 600mg plus Vit D 800 IU	Daily supplementation with 600mg Calcium plus 800IU Vitamin D3
DIETARY_SUPPLEMENT	Placebo	placebo tablets

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-09-01
• Completion: 2015-02-01
• First posted: 2010-04-14
• Last updated: 2015-02-04

Locations

1 site across 1 country: China