Trial Outcomes & Findings for Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers (NCT NCT01447433)

NCT ID: NCT01447433

Last Updated: 2012-08-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 53 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2012-08-01

Participant Flow

Participant were recruited through informational flyers and advertisements posted on campus of colleges and vocational schools in Pudong and Yangpu Districts in Shanghai, China. From April 20th to September 20th, 2011, a total of 129 out of 187 volunteers who answered our recruitment advertisements were invited for a pre-screening interview.

The pre-screening FFQ excluded 34 volunteers for habitual calcium intake>600mg/day. During screening, 16 were excluded for BMI<24kg/m2, 3 reported for using calcium supplements, 14 were on a diet, 2 refused to take calcium supplements, 1 refused to being taken blood samples, and 6 failed to sign the informed consents for personal reasons.

Participant milestones

Measure	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.	Control A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Overall Study STARTED	26	27
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Measure	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.	Control A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	3	3
Overall Study Protocol Violation	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Calcium+D n=26 Participants 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.	Control n=27 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	20.3 years STANDARD_DEVIATION 1.4 • n=5 Participants	20.4 years STANDARD_DEVIATION 0.8 • n=7 Participants	20.3 years STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment China	26 participants n=5 Participants	27 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Males were excluded from final analysis for statistical reasons.

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.

Outcome measures

Measure	Calcium+D n=21 Participants 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.	Control n=19 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Change in Body Weight	-3.9 kg Standard Deviation 1.7	-3.5 kg Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Males were excluded from final analysis for statistical reasons.

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

Outcome measures

Measure	Calcium+D n=21 Participants 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.	Control n=19 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass Body Fat Mass	-2.8 kg Standard Error 1.3	-1.9 kg Standard Error 1.3
Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass Body Lean Mass	-0.9 kg Standard Error 0.8	-1.4 kg Standard Error 0.9
Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass Visceral Fat Mass	-0.47 kg Standard Error 0.21	-0.29 kg Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Males were excluded from final analysis for statistical reasons.

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

Outcome measures

Measure	Calcium+D n=21 Participants 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.	Control n=19 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Change in Fat Percentage	-2.6 Percentage of body weight Standard Deviation 1.6	-1.5 Percentage of body weight Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Males were excluded from final analysis for statistical reasons.

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

Outcome measures

Measure	Calcium+D n=18 Participants 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.	Control n=18 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Change in Visceral Fat Area	-12.5 cm^2 Standard Deviation 6.2	-6.8 cm^2 Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Males were excluded from final analysis for statistical reasons.

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

Outcome measures

Measure	Calcium+D n=21 Participants 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.	Control n=19 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Change in Waist, Abdominal and Hip Circumference Waist Circumference	-6.2 cm Standard Deviation 5.7	-5.1 cm Standard Deviation 5.0
Change in Waist, Abdominal and Hip Circumference Abdominal Circumference	-4.6 cm Standard Deviation 4.4	-5.8 cm Standard Deviation 8.3
Change in Waist, Abdominal and Hip Circumference Hip Circumference	-4.2 cm Standard Deviation 2.9	-3.2 cm Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Males were excluded from final analysis for statistical reasons.

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.

Outcome measures

Measure	Calcium+D n=18 Participants 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.	Control n=18 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Change in Blood Pressure Systolic Blood Pressure	-8.3 mm Hg Standard Deviation 13.2	-12.1 mm Hg Standard Deviation 13.7
Change in Blood Pressure Diastolic Blood Pressure	-6.0 mm Hg Standard Deviation 9.8	-5.0 mm Hg Standard Deviation 9.3

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Males were excluded from final analysis for statistical reasons.

Outcome measures

Measure	Calcium+D n=21 Participants 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.	Control n=19 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Change in Lipid-lipoprotein Profile TC	-0.11 mmol/L Standard Deviation 0.43	-0.19 mmol/L Standard Deviation 0.45
Change in Lipid-lipoprotein Profile TG	0.02 mmol/L Standard Deviation 0.42	0.10 mmol/L Standard Deviation 0.55
Change in Lipid-lipoprotein Profile HDL	0.12 mmol/L Standard Deviation 0.53	-0.14 mmol/L Standard Deviation 0.48
Change in Lipid-lipoprotein Profile LDL	0.14 mmol/L Standard Deviation 0.51	0.12 mmol/L Standard Deviation 0.40

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Males were excluded from final analysis for statistical reasons.

Outcome measures

Measure	Calcium+D n=21 Participants 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.	Control n=19 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Change in Fasting Plasma Glucose	0.25 mmol/L Standard Deviation 0.33	0.37 mmol/L Standard Deviation 0.37

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Males were excluded from final analysis for statistical reasons.

Outcome measures

Measure	Calcium+D n=21 Participants 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.	Control n=19 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Change in Fasting Plasma Insulin	-1.18 mIU/L Standard Deviation 5.02	-0.31 mIU/L Standard Deviation 5.16

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Males were excluded from final analysis for statistical reasons.

Outcome measures

Measure	Calcium+D n=21 Participants 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.	Control n=19 Participants A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Change in Energy Intakes	-400.4 kcal/d Standard Deviation 252.0	-301.9 kcal/d Standard Deviation 310.1

Adverse Events

Calcium+D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Donglian Cai

Changhai Hospital

Phone: 86 21 81873168

Email: nutrition1226@126.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place