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

Naval Military Medical University

Status and phase: Completed; Phase 4

Conditions: Overweight; Obesity

Treatments: Drug: Calcium Carbonate; Behavioral: Energy restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT01447433

201011Z-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups, including a placebo group

Calcium+D

Experimental group

Description:

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.

Treatment:

Behavioral: Energy restriction

Drug: Calcium Carbonate

Control

Placebo Comparator group

Description:

A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.

Treatment:

Behavioral: Energy restriction