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

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ClinicalTrials.gov Identifier: NCT01103115
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
CHENG Chun-yiu Jack, Chinese University of Hong Kong

Study Description
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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).

Condition or disease Intervention/treatment Phase
Scoliosis Dietary Supplement: Calcium 600mg plus Vit D 400 IU Dietary Supplement: Calcium 600mg plus Vit D 800 IU Dietary Supplement: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?
Study Start Date : April 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103115


Locations
China
Prince of Wales Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Tsz-ping Lam Chinese University of Hong Kong
More Information
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Additional Information:
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong  This link exits the ClinicalTrials.gov site

Responsible Party: CHENG Chun-yiu Jack, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01103115     History of Changes
Other Study ID Numbers: AIS_Ca_VitD_01
First Posted: April 14, 2010    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by CHENG Chun-yiu Jack, Chinese University of Hong Kong:
Adolescent Idiopathic Scoliosis
AIS
low bone mass
 osteopenia
bone health
bone density

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
 Calcium, Dietary
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents