Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers

Study Overview
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Brief Summary
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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.

Detailed Description
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Due to the contradicting findings in the hypothesis of calcium supplementation on weight and fat loss, which might be explained by the difference in initial calcium intake, the present study is aimed to evaluate the effect of calcium plus vitamin D supplementation on accelerating weight and fat loss in overweight or obese subjects with very-low calcium consumption(<600mg/day). 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.

Official Title
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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

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Drug: Calcium Carbonate
* Behavioral: Energy restriction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium+D<br>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. | Drug: Calcium Carbonate<br>* tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks<br>* Other names: Code:1007300;Behavioral: Energy restriction<br>* A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.<br>|
| Placebo Comparator: Control<br>A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. | Behavioral: Energy restriction<br>* A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass. | Baseline and 12 weeks | 
| Change in Fat Percentage | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage. | Baseline and 12 weeks | 
| Change in Visceral Fat Area | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area. | Baseline and 12 weeks | 
| Change in Waist, Abdominal and Hip Circumference | Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm | Baseline and 12 weeks | 
| Change in Blood Pressure | Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer. | Baseline and 12 weeks | 
| Change in Lipid-lipoprotein Profile |  | Baseline and 12 weeks | 
| Change in Fasting Plasma Glucose |  | Baseline and 12 weeks | 
| Change in Fasting Plasma Insulin |  | Baseline and 12 weeks | 
| Change in Energy Intakes |  | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Calcium Carbonate, Vitamin D, Body weight, Body fat, Metabolic parameters, Energy restriction, Very-low calcium consumers, Overweight