Phase 4 N=53 Randomized Treatment

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

Obesity · Overweight

Bottom Line

View on ClinicalTrials.gov: NCT01447433 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2012

Primary outcome: Primary: Change in Body Weight — -3.9; -3.5 kg — p=0.441

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Calcium Carbonate (Drug); Energy restriction (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Changhai Hospital
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Body Weight	-3.9; -3.5	0.441
SECONDARY Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass	-2.8; -1.9; -0.9; -1.4; -0.47; -0.29	0.038 sig
SECONDARY Change in Fat Percentage	-2.6; -1.5	0.031 sig
SECONDARY Change in Visceral Fat Area	-12.5; -6.8	0.016 sig
SECONDARY Change in Waist, Abdominal and Hip Circumference	-6.2; -5.1; -4.6; -5.8; -4.2; -3.2	0.508
SECONDARY Change in Blood Pressure	-8.3; -12.1; -6.0; -5.0	0.404
SECONDARY Change in Lipid-lipoprotein Profile	-0.11; -0.19; 0.02; 0.10; 0.12; -0.14	0.565
SECONDARY Change in Fasting Plasma Glucose	0.25; 0.37	0.260
SECONDARY Change in Fasting Plasma Insulin	-1.18; -0.31	0.598
SECONDARY Change in Energy Intakes	-400.4; -301.9	0.275

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01447433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.