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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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?

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 330
Study Start Date: April 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   11 Years to 14 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
Study First Received: April 5, 2010
Last Updated: January 31, 2014
Health Authority: Hong Kong: Department of Health
China: The Government of the Hong Kong Special Administrative Region of the People's Republic of China

Keywords provided by 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
Calcium, Dietary
Vitamin D
Ergocalciferols
Calcium Carbonate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 14, 2014