Trial Outcomes & Findings for The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment (NCT NCT01371877)

Last Updated: 2023-09-21

Results Overview

The Unit of Measure is Efficacy. The primary outcome of this study is to determine if vitamin D supplementation reduces the medication usage in subjects with CUA. Thus, for the outcome of reduction in pills, at 12 weeks, subjects whose pill usage decreases by 2 or more pills per day will be classified as improved. Subjects whose pill consumption did not change or increased will be classified as unchanged.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

12 week intervention

Results posted on

2023-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	High Dose Vitamin D Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months. Vitamin D: Vitamin D 4000 IU per day for 3 months	Low Dose Vitamin D Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months. Vitamin D: Vitamin D 600 IU per day
Overall Study STARTED	21	21
Overall Study COMPLETED	21	17
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	High Dose Vitamin D Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months. Vitamin D: Vitamin D 4000 IU per day for 3 months	Low Dose Vitamin D Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months. Vitamin D: Vitamin D 600 IU per day
Overall Study 3 for unknown reasons and 1 pregnant	0	4

Baseline Characteristics

The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose Vitamin D n=21 Participants Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months. Vitamin D: Vitamin D 4000 IU per day for 3 months	Low Dose Vitamin D n=21 Participants Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months. Vitamin D: Vitamin D 600 IU per day	Total n=42 Participants Total of all reporting groups
Age, Continuous	43.9 years n=5 Participants	43.1 years n=7 Participants	43.5 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 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	0 Participants n=5 Participants	1 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	19 Participants n=7 Participants	39 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
Region of Enrollment United States	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants
Baseline vitamin D level	28.86 ng/mL STANDARD_DEVIATION 10.1 • n=5 Participants	37.2 ng/mL STANDARD_DEVIATION 15.5 • n=7 Participants	33.0 ng/mL STANDARD_DEVIATION 13.6 • n=5 Participants

PRIMARY outcome

Timeframe: 12 week intervention

Outcome measures

Outcome measures
Measure	High Dose Vitamin D n=21 Participants Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months. Vitamin D: Vitamin D 4000 IU per day for 3 months	Low Dose Vitamin D n=17 Participants Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months. Vitamin D: Vitamin D 600 IU per day
Medication Usage Baseline medication usage	2.8 number of pills/day Standard Deviation 2.6	4.6 number of pills/day Standard Deviation 3.2
Medication Usage 3 month medication usage	2.0 number of pills/day Standard Deviation 2.9	4.9 number of pills/day Standard Deviation 2.8

SECONDARY outcome

Timeframe: 3 month intervention

The Unit of Measure is Efficacy. The Total Urticaria Severity Score (USS) ranges from 0 to 93, higher scores = worse symptoms. This secondary outcome of this study is to determine if high dose vitamin D supplementation improves the urticaria severity score (USS). The change in USS will be compared between the groups using the independent sample t-test (assuming the distribution is normal). Logistic regression and multiple linear regression will be used to adjust for possible confounders.

Outcome measures

Outcome measures
Measure	High Dose Vitamin D n=21 Participants Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months. Vitamin D: Vitamin D 4000 IU per day for 3 months	Low Dose Vitamin D n=17 Participants Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months. Vitamin D: Vitamin D 600 IU per day
Total Urticaria Severity Score at 3 Months Baseline Total Urticaria Score	41.14 units on a scale Standard Error 2.36	40.1 units on a scale Standard Error 3.4
Total Urticaria Severity Score at 3 Months 1 week Total Urticaria Score	25.48 units on a scale Standard Error 3.34	29.24 units on a scale Standard Error 3.93
Total Urticaria Severity Score at 3 Months 3 month Total Urticaria Score	15.0 units on a scale Standard Error 2.9	24.1 units on a scale Standard Error 2.9

SECONDARY outcome

Timeframe: 3 month study trial

Population: No significant adverse events. All subjects in the high vitamin D3 group completed the study; 4 subjects in the low vitamin D3 600 IU/day withdrew from the study (1 for pregnancy and 3 unknown). There was no evidence of hypercalcemia.

Unit of Measure is Safety and Tolerability. The number of participants with adverse events will be compared between the groups using the independent sample t-test (assuming the distribution is normal).

Outcome measures

Outcome measures
Measure	High Dose Vitamin D n=21 Participants Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months. Vitamin D: Vitamin D 4000 IU per day for 3 months	Low Dose Vitamin D n=21 Participants Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months. Vitamin D: Vitamin D 600 IU per day
Number of Participants With Adverse Events	0 participants	0 participants

Adverse Events

High Dose Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Dose Vitamin D

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

Dr. Jill Poole

University of Nebraska Medical Center

Phone: 402-559-4087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place