Overview

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

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Changhai Hospital
Treatments:
Calcium
Calcium Carbonate
Calcium, Dietary
Ergocalciferols
Vitamin D
Vitamins
Criteria
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