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

Primary Purpose

Obesity, Overweight

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Calcium Carbonate

Energy restriction

About this trial

This is an interventional treatment trial for Obesity focused on measuring Calcium Carbonate, Vitamin D, Body weight, Body fat, Metabolic parameters, Energy restriction, Very-low calcium consumers, Obesity, Overweight

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calcium+D

Control

Arm Description

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.

A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.

Outcomes

Primary Outcome Measures

Change in Body Weight

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

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

BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.

Change in Visceral Fat Area

BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.

Change in Waist, Abdominal and Hip Circumference

Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm

Change in Blood Pressure

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

Change in Fasting Plasma Glucose

Change in Fasting Plasma Insulin

Change in Energy Intakes

Full Information

NCT ID

NCT01447433

First Posted

October 4, 2011

Last Updated

July 26, 2012

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01447433

Brief Title

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

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight

Keywords

Calcium Carbonate, Vitamin D, Body weight, Body fat, Metabolic parameters, Energy restriction, Very-low calcium consumers, Obesity, Overweight

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Calcium+D

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.

Intervention Type

Drug

Intervention Name(s)

Calcium Carbonate

Other Intervention Name(s)

Caltrate® 600 + D, Code:1007300

Intervention Description

tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks

Intervention Type

Behavioral

Intervention Name(s)

Energy restriction

Intervention Description

A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.

Primary Outcome Measure Information:

Title

Change in Body Weight

Description

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.

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass

Description

BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.

Time Frame

Baseline and 12 weeks

Title

Change in Fat Percentage

Description

BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.

Time Frame

Baseline and 12 weeks

Title

Change in Visceral Fat Area

Description

BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.

Time Frame

Baseline and 12 weeks

Title

Change in Waist, Abdominal and Hip Circumference

Description

Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm

Time Frame

Baseline and 12 weeks

Title

Change in Blood Pressure

Description

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.

Time Frame

Baseline and 12 weeks

Title

Change in Lipid-lipoprotein Profile

Time Frame

Baseline and 12 weeks

Title

Change in Fasting Plasma Glucose

Time Frame

Baseline and 12 weeks

Title

Change in Fasting Plasma Insulin

Time Frame

Baseline and 12 weeks

Title

Change in Energy Intakes

Time Frame

Baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donglian Cai, Master

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changhai Hospital

City

Shanghai

ZIP/Postal Code

200433

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

23297844

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. Erratum In: Nutr J. 2013;12:43.

Results Reference

derived

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

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