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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

Tracking Information
First Submitted Date  ICMJE April 5, 2010
First Posted Date  ICMJE April 14, 2010
Last Update Posted Date February 4, 2015
Study Start Date  ICMJE April 2010
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01103115 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)
Official Title  ICMJE Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Scoliosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Subjects in this group will take the placebo tablets
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Ca600mg+VitD400IU
    subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3
    Intervention: Dietary Supplement: Calcium 600mg plus Vit D 400 IU
  • Active Comparator: Ca600mg+VitD800IU
    subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3
    Intervention: Dietary Supplement: Calcium 600mg plus Vit D 800 IU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2010)
330
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 11 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01103115
Other Study ID Numbers  ICMJE AIS_Ca_VitD_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CHENG Chun-yiu Jack, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tsz-ping Lam Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP