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Completed

NCT Number: NCT01447433

Effect of Calcium + Vitamin D Supplementation on Weight Management in 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changhai Hospital

Shanghai, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium Carbonate

Drug

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

Other names: Caltrate® 600 + D, Code:1007300

Energy restriction

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Change in Fat Percentage

    Time frame: Baseline and 12 weeks

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

  3. 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.

  4. 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

  5. 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.

  6. Change in Lipid-lipoprotein Profile

    Time frame: Baseline and 12 weeks

  7. Change in Fasting Plasma Glucose

    Time frame: Baseline and 12 weeks

  8. Change in Fasting Plasma Insulin

    Time frame: Baseline and 12 weeks

  9. Change in Energy Intakes

    Time frame: Baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 6, 2011
Registry last updated
Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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