Clinical trial NCT01447433: Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Overweight
Keywords: Calcium Carbonate
Vitamin D
Body weight
Body fat
Metabolic parameters
Energy restriction
Very-low calcium consumers
Obesity
Overweight
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass
timeFrame: Baseline and 12 weeks
measure: Change in Fat Percentage
timeFrame: Baseline and 12 weeks
measure: Change in Visceral Fat Area
timeFrame: Baseline and 12 weeks
measure: Change in Waist, Abdominal and Hip Circumference
timeFrame: Baseline and 12 weeks
measure: Change in Blood Pressure
timeFrame: Baseline and 12 weeks
measure: Change in Lipid-lipoprotein Profile
timeFrame: Baseline and 12 weeks
measure: Change in Fasting Plasma Glucose
timeFrame: Baseline and 12 weeks
measure: Change in Fasting Plasma Insulin
timeFrame: Baseline and 12 weeks
measure: Change in Energy Intakes
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Donglian Cai, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.