Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers
NCT ID: NCT01447433
Last Updated: 2012-08-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
53 participants
INTERVENTIONAL
2011-04-30
2012-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The hypotheses to be tested are:
Calcium plus vitamin D supplementation is conducive to body weight and fat loss in overweight or obese young adults during energy restriction 12 weeks after randomization.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Calcium+D
Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Calcium Carbonate
tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks
Energy restriction
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Control
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Energy restriction
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Calcium Carbonate
tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks
Energy restriction
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Habitual calcium intake below 600mg/d
* Overweight or obese (BMI between 24 and 35kg/m2, refer to the Chinese standard)
* Stable body weight (body weight change less than 1kg two months before screening)
* Less than 3 times of 20min of physical exercise per week
* Signed written informed consent
Exclusion Criteria
* Pregnant or lactating woman
* Use of calcium supplements, oral antidiabetic agents, antihyperlipidemics or any other medications affecting metabolism 30 days before randomization
* Participating in another weight loss programs (i.e. taking oral pharmacotherapeutic agents and/or herbal preparations intended for the management of obesity; excessive physical activity; be on a diet)
* On special diets (i.e. vegetarian)
* Presently taking or have recently taken a prescription drug such as fluoroquinolone antibiotics, tetracycline, or levothyroxine (thyroid medication)
* Participating in another clinical trial 6 months before randomization
* Unlikely to be compliant (i.e. alcohol, drug abuse)
* Refusal or inability to give informed consent to participate in the study
18 Years
25 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Changhai Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Donglian Cai
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Donglian Cai, Master
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Changhai Hospital
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zhu W, Cai D, Wang Y, Lin N, Hu Q, Qi Y, Ma S, Amarasekara S. Calcium plus vitamin D3 supplementation facilitated fat loss in overweight and obese college students with very-low calcium consumption: a randomized controlled trial. Nutr J. 2013 Jan 8;12:8. doi: 10.1186/1475-2891-12-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201011Z-02
Identifier Type: -
Identifier Source: org_study_id