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

July 26, 2012 updated by: Donglian Cai, Changhai Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Baseline and 12 weeks
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.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass
Time Frame: Baseline and 12 weeks
BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.
Baseline and 12 weeks
Change in Fat Percentage
Time Frame: Baseline and 12 weeks
BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.
Baseline and 12 weeks
Change in Visceral Fat Area
Time Frame: Baseline and 12 weeks
BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.
Baseline and 12 weeks
Change in Waist, Abdominal and Hip Circumference
Time Frame: Baseline and 12 weeks
Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm
Baseline and 12 weeks
Change in Blood Pressure
Time Frame: Baseline and 12 weeks
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.
Baseline and 12 weeks
Change in Lipid-lipoprotein Profile
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in Fasting Plasma Glucose
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in Fasting Plasma Insulin
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in Energy Intakes
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Donglian Cai, Master, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 26, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201011Z-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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