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

February 2, 2015 updated by: CHENG Chun-yiu Jack, Chinese University of Hong Kong

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong SAR, China
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-year time point

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-year time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

April 5, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (Estimate)

April 14, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIS_Ca_VitD_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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