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
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Condition or disease | Intervention/treatment | Phase |
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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 (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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Subjects in this group will take the placebo tablets
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Dietary Supplement: Placebo
placebo tablets |
Active Comparator: Ca600mg+VitD400IU
subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3
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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 |
- 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.
- 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.

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Ages Eligible for Study: | 11 Years to 14 Years (Child) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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
China | |
Prince of Wales Hospital | |
Hong Kong SAR, China |
Principal Investigator: | Tsz-ping Lam | Chinese University of Hong Kong |
Responsible Party: | CHENG Chun-yiu Jack, Professor, Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT01103115 |
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 |
Adolescent Idiopathic Scoliosis AIS low bone mass |
osteopenia bone health bone density |
Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases Calcium, Dietary Vitamin D Calcium Carbonate Calcium Calcium-Regulating Hormones and Agents |
Physiological Effects of Drugs Bone Density Conservation Agents Vitamins Micronutrients Nutrients Growth Substances Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |