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Trial Outcomes & Findings for Vitamin D Replacement After Kidney Transplant (NCT NCT00748618)

NCT ID: NCT00748618

Last Updated: 2024-10-26

Results Overview

The 6 month change (6 month - Baseline) was compared between the two treatment arms of vitamin D supplements for normalizing vitamin D concentrations. Higher change values indicate improvement in vitamin D levels.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

116 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2024-10-26

Participant Flow

165 subjects were screened, and 93 subjects were eligible and were randomized to treatments. Three patients voluntarily withdrew consent immediately following randomization. A total of 90 subjects received treatments.

Participant milestones

Participant milestones
Measure
Standard Vitamin Treatment
Standard vitamin treatment vitamin D3: Participants receive 10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of Vitamin D3
50,000 I.U. of vitamin D3 vitamin D3: Participants receive 50,000 I.U./wk of vitamin D3 orally for 6 months
Overall Study
STARTED
46
44
Overall Study
COMPLETED
45
44
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Standard Vitamin Treatment
Standard vitamin treatment vitamin D3: Participants receive 10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of Vitamin D3
50,000 I.U. of vitamin D3 vitamin D3: Participants receive 50,000 I.U./wk of vitamin D3 orally for 6 months
Overall Study
Adverse Event
1
0

Baseline Characteristics

Vitamin D Replacement After Kidney Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard Vitamin Treatment
n=46 Participants
Standard vitamin treatment vitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of Vitamin D3
n=44 Participants
50,000 I.U. of vitamin D3 vitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months
Total
n=90 Participants
Total of all reporting groups
Age, Continuous
55.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
52.1 years
STANDARD_DEVIATION 12.1 • n=7 Participants
53.8 years
STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male
Female
27 Participants
n=5 Participants
21 Participants
n=7 Participants
48 Participants
n=5 Participants
Sex: Female, Male
Male
19 Participants
n=5 Participants
23 Participants
n=7 Participants
42 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
43 Participants
n=5 Participants
40 Participants
n=7 Participants
83 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=5 Participants
7 Participants
n=7 Participants
12 Participants
n=5 Participants
Race (NIH/OMB)
White
40 Participants
n=5 Participants
37 Participants
n=7 Participants
77 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Vitamin D Concentration
27.2 ng/ml
STANDARD_DEVIATION 5.3 • n=5 Participants
26.3 ng/ml
STANDARD_DEVIATION 6.9 • n=7 Participants
26.7 ng/ml
STANDARD_DEVIATION 6.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Patients who had baseline and 6 month 25-hydroxy Vitamin D levels measured

The 6 month change (6 month - Baseline) was compared between the two treatment arms of vitamin D supplements for normalizing vitamin D concentrations. Higher change values indicate improvement in vitamin D levels.

Outcome measures

Outcome measures
Measure
Standard Vitamin Treatment
n=45 Participants
Standard vitamin treatment vitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of Vitamin D3
n=43 Participants
50,000 I.U. of vitamin D3 vitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months
Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.
8 ng/ml
Interval -10.0 to 32.0
29 ng/ml
Interval -9.0 to 61.0

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Available data from patients who had baseline and 6 month parathyroid hormone concentration levels obtained.

The 6 month change (6 month - Baseline) in parathyroid hormone concentration was compared between the two treatment arms.

Outcome measures

Outcome measures
Measure
Standard Vitamin Treatment
n=45 Participants
Standard vitamin treatment vitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of Vitamin D3
n=43 Participants
50,000 I.U. of vitamin D3 vitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months
The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.
1.0 pg/ml
Interval -120.6 to 81.0
-9.0 pg/ml
Interval -94.0 to 200.0

SECONDARY outcome

Timeframe: 6 months

Population: Available data from patients who had baseline and 6 month spot urine protein-creatinine ratio levels obtained.

The 6 month change (6 month - Baseline) in spot urine protein-creatinine ratio was compared between the two treatment arms.

Outcome measures

Outcome measures
Measure
Standard Vitamin Treatment
n=44 Participants
Standard vitamin treatment vitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of Vitamin D3
n=42 Participants
50,000 I.U. of vitamin D3 vitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months
The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.
-0.45 mg/mmol
Interval -1215.4 to 1906.7
-1.95 mg/mmol
Interval -1652.7 to 798.8

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Available data from patients who had baseline and 6 month HsCRP levels obtained

The 6 month change in High-sensitivity C-reactive protein (HsCRP) levels was compared between the two treatment arms.

Outcome measures

Outcome measures
Measure
Standard Vitamin Treatment
n=45 Participants
Standard vitamin treatment vitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of Vitamin D3
n=42 Participants
50,000 I.U. of vitamin D3 vitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months
The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.
0.3 mg/dl
Interval -13.5 to 18.4
0.15 mg/dl
Interval -42.2 to 51.3

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Available data from patients who had baseline and 6 month HOMA-IR levels obtained.

The 6 month change (6 month - Baseline) in insulin resistance was assessed with HOMA-IR (Homeostatic Model Assessment-Insulin Resistance), which is calculated by fasting glucose (mg/dL) X fasting insulin (mU/L) /405.

Outcome measures

Outcome measures
Measure
Standard Vitamin Treatment
n=30 Participants
Standard vitamin treatment vitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of Vitamin D3
n=26 Participants
50,000 I.U. of vitamin D3 vitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months
The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months
-0.6 (microU/L) x (nmol/L)
Interval -7.2 to 4.3
0.1 (microU/L) x (nmol/L)
Interval -7.0 to 8.0

Adverse Events

Standard Vitamin Treatment

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

50,000 I.U. of Vitamin D3

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Standard Vitamin Treatment
n=46 participants at risk
Standard vitamin treatment vitamin D3: Participants receive 10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of Vitamin D3
n=44 participants at risk
50,000 I.U. of vitamin D3 vitamin D3: Participants receive 50,000 I.U./wk of vitamin D3 orally for 6 months
Gastrointestinal disorders
Viral gastroenteritis
0.00%
0/46
2.3%
1/44 • Number of events 1
Renal and urinary disorders
Reoccurring UTI
0.00%
0/46
2.3%
1/44 • Number of events 1
Renal and urinary disorders
Enteric Conversion
0.00%
0/46
2.3%
1/44 • Number of events 1

Other adverse events

Other adverse events
Measure
Standard Vitamin Treatment
n=46 participants at risk
Standard vitamin treatment vitamin D3: Participants receive 10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of Vitamin D3
n=44 participants at risk
50,000 I.U. of vitamin D3 vitamin D3: Participants receive 50,000 I.U./wk of vitamin D3 orally for 6 months
Endocrine disorders
Elevated calcium
2.2%
1/46 • Number of events 1
4.5%
2/44 • Number of events 3

Additional Information

Fang Yu

University of Nebraska Medical Center

Phone: (402) 559-9436

Results disclosure agreements

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