Overview
Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers
Status:
Completed
Completed
Trial end date:
2012-02-01
2012-02-01
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Changhai HospitalTreatments:
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