Trial Outcomes & Findings for Cholecalciferol and Flu Vaccine in Treating Healthy Participants (NCT NCT01561989)
NCT ID: NCT01561989
Last Updated: 2020-03-10
Results Overview
Descriptive statistics and chi-square tests will be used to assess for differences in the occurrence of self-reported flu-like illnesses in the study population.
TERMINATED
NA
11 participants
At 4 weeks post-vaccination
2020-03-10
Participant Flow
unable to meet accrual objective. study closed.
unable to meet accrual objective. study closed.
Participant milestones
| Measure |
Arm I
Patients receive low-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.
Unable to meet accrual objective. Arm closed with study termination.
|
Arm II
Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.
Unable to meet accrual objective. Arm closed with study termination.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Arm I
Patients receive low-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.
Unable to meet accrual objective. Arm closed with study termination.
|
Arm II
Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.
Unable to meet accrual objective. Arm closed with study termination.
|
|---|---|---|
|
Overall Study
accural target not met.
|
5
|
6
|
Baseline Characteristics
Cholecalciferol and Flu Vaccine in Treating Healthy Participants
Baseline characteristics by cohort
| Measure |
Arm I (400 IU Cholecalciferol and Vaccine Therapy)
n=5 Participants
Patients receive low-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.
cholecalciferol: Given PO
questionnaire administration: Ancillary studies
trivalent influenza vaccine: Given IM
|
Arm II (4,000 IU Cholecalciferol and Vaccine Therapy)
n=6 Participants
Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.
cholecalciferol: Given PO
questionnaire administration: Ancillary studies
trivalent influenza vaccine: Given IM
|
Total
n=11 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
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
unknown
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 4 weeks post-vaccinationPopulation: No subjects were treated prior to study closure due to lack of accrual.
Descriptive statistics and chi-square tests will be used to assess for differences in the occurrence of self-reported flu-like illnesses in the study population.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 24 weeks post-vaccinationPopulation: unable to accrue participants, study closed, no analyses completed.
Descriptive statistics will be used to assess for differences in the occurrence of self-reported flu-like illnesses in the study population. Will be estimated with confidence intervals at each time point. Tested by Wald Chi-square test, and the odds ratio (with confidence intervals) will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to April 1, 2012Population: No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.
occurrences of flu-like illness
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to week 24Population: No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.
Relationship between 25-hydroxy vitamin D3 levels at time of vaccination and immunologic responses following administration of the injected seasonal (2012-2013) trivalent influenza vaccine (Intervention component)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initial treatment until the end of study (April 1, 2012); up to 24-weeks.Population: No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.
occurrences of flu like illness (intervention arm)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.
Association between SNPs and polymorphisms in the DNA sequence of vitamin-D3 metabolizing enzymes, measures of vitamin-D3 metabolism (24,25 OH vitamin D3) and response to seasonal (2012-201) trivalent influenza vaccine (Intervention component)
Outcome measures
Outcome data not reported
Adverse Events
Cholecalciferal + Flu Vaccine
Flu Vaccine Alone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place