Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers
A Randomized, Open-label, Parallel Groups-controlled Clinical Trial to Evaluate the Effect of Calcium Plus Vitamin D Supplementation on Weight Management in Overweight and Obese Very-low Calcium Consumers
1 other identifier
interventional
53
1 country
1
Brief Summary
The purpose of the study is to determine whether calcium plus vitamin D supplementation is conducive to weight and fat loss during energy restriction in very-low calcium consumers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 obesity
Started Apr 2011
Shorter than P25 for phase_4 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 4, 2011
CompletedFirst Posted
Study publicly available on registry
October 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
March 6, 2012
CompletedAugust 1, 2012
July 1, 2012
9 months
October 4, 2011
January 3, 2012
July 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Body Weight
Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.
Baseline and 12 weeks
Secondary Outcomes (9)
Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass
Baseline and 12 weeks
Change in Fat Percentage
Baseline and 12 weeks
Change in Visceral Fat Area
Baseline and 12 weeks
Change in Waist, Abdominal and Hip Circumference
Baseline and 12 weeks
Change in Blood Pressure
Baseline and 12 weeks
- +4 more secondary outcomes
Study Arms (2)
Calcium+D
EXPERIMENTALCalcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Control
PLACEBO COMPARATORA balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Interventions
tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Eligibility Criteria
You may qualify if:
- Male or female 18 to 25 years of age, generally healthy
- 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
You may not qualify if:
- Coronary heart disease, hypertension, diabetes; hepatic insufficiency or renal insufficiency, hyper- or hypothyroidism, mal-absorption, cholesterol concentrations requiring pharmaceutical treatment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, 200433, China
Related Publications (1)
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.
PMID: 23297844DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study sample was mostly women.
Results Point of Contact
- Title
- Prof. Donglian Cai
- Organization
- Changhai Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Donglian Cai, Master
Changhai Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 4, 2011
First Posted
October 6, 2011
Study Start
April 1, 2011
Primary Completion
January 1, 2012
Study Completion
February 1, 2012
Last Updated
August 1, 2012
Results First Posted
March 6, 2012
Record last verified: 2012-07