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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447433
• Other study ID #: 201011Z-02
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2011
• Last updated: July 26, 2012
• Start date: April 2011
• Est. completion date: February 2012

Study information

• Verified date: July 2012
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Calcium Carbonate
tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks

Behavioral:
• Energy restriction
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 12 weeks	No
Secondary	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.	Baseline and 12 weeks	No
Secondary	Change in Fat Percentage	BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.	Baseline and 12 weeks	No
Secondary	Change in Visceral Fat Area	BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.	Baseline and 12 weeks	No
Secondary	Change in Waist, Abdominal and Hip Circumference	Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm	Baseline and 12 weeks	No
Secondary	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.	Baseline and 12 weeks	No
Secondary	Change in Lipid-lipoprotein Profile		Baseline and 12 weeks	No
Secondary	Change in Fasting Plasma Glucose		Baseline and 12 weeks	No
Secondary	Change in Fasting Plasma Insulin		Baseline and 12 weeks	No
Secondary	Change in Energy Intakes		Baseline and 12 weeks	No