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OpenTrials
Completed

NCT Number: NCT01103115

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

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).

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Key information

Age range

11 year–14 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Prince of Wales Hospital

Hong Kong SAR, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium 600mg plus Vit D 400 IU

Dietary Supplement

Daily supplementation with 600mg Calcium plus 400IU Vitamin D3

Calcium 600mg plus Vit D 800 IU

Dietary Supplement

Daily supplementation with 600mg Calcium plus 800IU Vitamin D3

Placebo

Dietary Supplement

placebo tablets

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Apr 14, 2010
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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