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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Donglian Cai, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01447433
First received: October 4, 2011
Last updated: July 26, 2012
Last verified: July 2012

October 4, 2011
July 26, 2012
April 2011
January 2012   (final data collection date for primary outcome measure)
Change in Body Weight [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.
Change in Body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01447433 on ClinicalTrials.gov Archive Site
  • Change in Body Fat Mass,Body Lean Mass and Visceral Fat Mass [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.
  • Change in Fat Percentage [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.
  • Change in Visceral Fat Area [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.
  • Change in Waist, Abdominal and Hip Circumference [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm
  • Change in Blood Pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer.
  • Change in Lipid-lipoprotein Profile [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Insulin [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in Energy Intakes [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in body fat [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    including changes in total body fat and visceral fat
  • Changes in anthropometric values [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    including waist circumference, abdominal circumference and hipline
  • Changes in metabolic profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    including fasting triglyceride, cholesterol, HDL, LDL, blood glucose and insulin, as well as blood pressure
Not Provided
Not Provided
 
Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Overweight
  • Drug: Calcium Carbonate
    tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks
    Other Names:
    • Caltrate® 600 + D
    • Code:1007300
  • Behavioral: Energy restriction
    A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
  • Experimental: Calcium+D
    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.
    Interventions:
    • Drug: Calcium Carbonate
    • Behavioral: Energy restriction
  • Placebo Comparator: Control
    A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
    Intervention: Behavioral: Energy restriction
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
February 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01447433
201011Z-02
No
Donglian Cai, Changhai Hospital
Changhai Hospital
Not Provided
Principal Investigator: Donglian Cai, Master Changhai Hospital
Changhai Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP