Trial Outcomes & Findings for Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease (NCT NCT01161407)

NCT ID: NCT01161407

Last Updated: 2014-07-29

Results Overview

Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2014-07-29

Participant Flow

Participant milestones

Measure	Calcium Then Placebo Crossover order was calcium then placebo, separated by at least a 3 week washout period. Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration.	Placebo Then Calcium Crossover order was placebo then calcium, separated by at least a 3 week washout period. Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration.
Overall Study STARTED	6	6
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Calcium Then Placebo Crossover order was calcium then placebo, separated by at least a 3 week washout period. Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration.	Placebo Then Calcium Crossover order was placebo then calcium, separated by at least a 3 week washout period. Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration.
Overall Study Protocol Violation	3	1

Baseline Characteristics

Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Calcium Then Placebo n=6 Participants Crossover order was calcium then placebo, separated by at least a 3 week washout period. Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration.	Placebo Then Calcium n=6 Participants Crossover order was placebo then calcium, separated by at least a 3 week washout period. Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration.	Total n=12 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	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	54.0 years STANDARD_DEVIATION 8.1 • n=5 Participants	60.8 years STANDARD_DEVIATION 5.3 • n=7 Participants	57.4 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces).

Outcome measures

Measure	Placebo n=8 Participants	Calcium n=8 Participants
Calcium Balance	61 mg/d calcium Standard Error 60	508 mg/d calcium Standard Error 60

SECONDARY outcome

Timeframe: 2 weeks

Phosphorus balance is measured by dietary phosphorus intake (mg/d) minus phosphorus excretion (mg/d) from both urine and feces.

Outcome measures

Measure	Placebo n=8 Participants	Calcium n=8 Participants
Phosphorus Balance	95 mg/d phosphorus Standard Error 29	153 mg/d phosphorus Standard Error 29

SECONDARY outcome

Timeframe: 2 weeks

Calcium kinetics was determined by a calcium radiotracer. Bone balance is the difference between bone formation and bone resorption estimated by calcium kinetic modeling.

Outcome measures

Measure	Placebo n=8 Participants	Calcium n=8 Participants
"Bone Balance" From Calcium Kinetics	62 mg/d calcium Standard Error 42	259 mg/d calcium Standard Error 42

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Calcium

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

Kathleen M. Hill Gallant

Purdue University

Phone: 765-494-0101

Email: hillgallant@purdue.edu

Results disclosure agreements

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

Restriction type: GT60