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
  Purpose

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.


Condition Intervention Phase
Obesity
Overweight
Drug: Calcium Carbonate
Behavioral: Energy restriction
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: April 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Placebo Comparator: Control
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Behavioral: Energy restriction
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.

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

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447433

Locations
China
Changhai Hospital
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
Principal Investigator: Donglian Cai, Master Changhai Hospital
  More Information

No publications provided by Changhai Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donglian Cai, Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT01447433     History of Changes
Other Study ID Numbers: 201011Z-02
Study First Received: October 4, 2011
Results First Received: January 3, 2012
Last Updated: July 26, 2012
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Changhai Hospital:
Calcium Carbonate
Vitamin D
Body weight
Body fat
Metabolic parameters
Energy restriction
Very-low calcium consumers
Obesity
Overweight

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms
Calcium Carbonate
Calcium, Dietary
Ergocalciferols
Vitamin D
Vitamins
Antacids
Bone Density Conservation Agents
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014