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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CHENG Chun-yiu Jack, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01103115
First received: April 5, 2010
Last updated: January 31, 2014
Last verified: January 2014

April 5, 2010
January 31, 2014
April 2010
September 2014   (final data collection date for primary outcome measure)
Bone mineral density [ Time Frame: 2-year time point ] [ Designated as safety issue: No ]
To determine the effects of calcium and vitamin D intervention on improving bone mineral density of skeletally immature AIS girls with low bone mass.
Same as current
Complete list of historical versions of study NCT01103115 on ClinicalTrials.gov Archive Site
Curve severity [ Time Frame: 2-year time point ] [ Designated as safety issue: No ]
To determine the effects of calcium and vitamin D intervention on preventing curve progression of skeletally immature AIS girls with low bone mass.
Same as current
Not Provided
Not Provided
 
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?

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Scoliosis
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
330
March 2015
September 2014   (final data collection date for primary outcome measure)

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.
Female
11 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01103115
AIS_Ca_VitD_01
No
CHENG Chun-yiu Jack, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Tsz-ping Lam Chinese University of Hong Kong
Chinese University of Hong Kong
January 2014

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