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

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:

Genetics Home Reference related topics: adolescent idiopathic scoliosis

MedlinePlus related topics: Bone Density Calcium Minerals Scoliosis Vitamin D

Drug Information available for: Calcium Gluconate Calcium carbonate Vitamin D

U.S. FDA Resources

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.


Enrollment:	330
Study Start Date:	April 2010
Study Completion Date:	February 2015
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 (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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
Study First Received:	April 5, 2010
Last Updated:	February 2, 2015
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 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

ClinicalTrials.gov processed this record on September 29, 2016