Trial Outcomes & Findings for Vitamin D in Preschoolers With Viral-induced Asthma (NCT NCT02197702)

NCT ID: NCT02197702

Last Updated: 2024-12-09

Results Overview

Group difference in the adjusted change from baseline 25OHD over 7 months

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 47 participants
• Primary outcome timeframe: During the 7-month follow-up period
• Results posted on: 2024-12-09

Participant Flow

Participant milestones

Measure	Placebo Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter	Vitamin D Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter
Overall Study STARTED	24	23
Overall Study Withdrew at Visit 1	0	1
Overall Study Withdrew at Visit 2	1	1
Overall Study Withdrew at Visit 3	0	2
Overall Study Analysed for Main Outcome	23	22
Overall Study COMPLETED	23	19
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D in Preschoolers With Viral-induced Asthma

Baseline characteristics by cohort

Measure	Placebo n=24 Participants Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter	Vitamin D n=23 Participants Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Total n=47 Participants Total of all reporting groups
Age, Continuous	2.9 years STANDARD_DEVIATION 1.2 • n=5 Participants	2.9 years STANDARD_DEVIATION 0.9 • n=7 Participants	2.9 years STANDARD_DEVIATION 1.0 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Canada	24 participants n=5 Participants	23 participants n=7 Participants	47 participants n=5 Participants
Vitamin D intake IU/day -Median (25%, 75%)	238 IU/day n=5 Participants	182 IU/day n=7 Participants	215 IU/day n=5 Participants
Serum vitamin D <75 nmol/L - n (%)	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the 7-month follow-up period

Group difference in the adjusted change from baseline 25OHD over 7 months

Outcome measures

Measure	Vitamin D n=22 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=23 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Change From Baseline in Serum 25OHD	9.6 nmol/L Interval -6.6 to 19.6	4.3 nmol/L Interval -6.6 to 15.1

SECONDARY outcome

Timeframe: at 3.5 and 7 months

Population: The numbers of participants analyzed in Placebo and Vitamin D groups were 23 and 19 at 3.5 months time point, and 22 and 18 at 7 months time point.

Group difference in the number of participants with total 25OHD ≥75 nmol/L

Outcome measures

Measure	Vitamin D n=19 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=23 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Number of Participants With Total 25OHD ≥75 Nmol/L at 3.5 months	12 Participants	9 Participants
Number of Participants With Total 25OHD ≥75 Nmol/L at 7 months	10 Participants	8 Participants

SECONDARY outcome

Timeframe: During the 7-month follow-up period

Population: The numbers of participants analyzed were 24 in Placebo and 23 in Vitamine D groups.

Group difference in the number of emergency department visits for asthma per child

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Emergency Department Visit for an Asthma Flare-up	1.04 visits/child Interval 0.7 to 1.56	1.00 visits/child Interval 0.67 to 1.49

OTHER_PRE_SPECIFIED outcome

Timeframe: At any point during the 7-month follow-up period

Group difference in the number of participants with ≥1 occurrence of hypercalciuria (urinary calcium: creatinine greater than 1.25mmol/mmol for children aged 1-2yrs or greater than 1mmol/mmol for those aged 2-5yrs)

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Hypercalciuria	4 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At any point during the 7-month follow-up period

Number of Participants with ≥1 occurrence of elevated serum 25OHD (greater than 225 nmol/L)

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Elevated Serum 25-hydroxyvitamin D (25OHD)	6 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At any point during the 7-month follow-up period

Number of participants with ≥1 occurrence of a clinically significant perturbation of the calcium homeostasis (serum Ca, Ph, Alkaline phosphatase), defined as outside normal laboratory values

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Perturbation of the Calcium Homeostasis	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During the 7-month follow-up period

Adjusted Incidence proportion of URTIs (the event rate per child occurring during the 7-month follow up period)

Outcome measures

Measure	Vitamin D n=22 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=22 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Number of URTIs (Verbal Report)	4.48 number of URTI/child Interval 3.66 to 5.49	4.12 number of URTI/child Interval 3.37 to 5.03

OTHER_PRE_SPECIFIED outcome

Timeframe: During the 7-month follow-up period

Group difference in the number of reported viral upper respiratory tract infections reported in the ADYC diary.

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Viral Upper Respiratory Tract Infections (URTI)	3.63 Viral URTI/child Interval 2.7 to 4.87	4.24 Viral URTI/child Interval 3.32 to 5.42

OTHER_PRE_SPECIFIED outcome

Timeframe: During the 7-month follow-up period

Group difference in the cumulative daily use of rescue β2-agonist use, standardized over 1 week, as documented by parents on the 'Asthma Flare-up Diary for Young CHildren' (ADYCs) during a URTI or an asthma exacerbation. A cumulative number of inhalations documented in ADYC were divided by the number of days of asthma exacerbation and multiplied by 7 days. Albuterol doses received during acute care visits and hospital admissions were not considered.

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Rescue β2-agonist Use During an Asthma Flare-up (Standardized Over 7 Days)	40.1 cumulative number of puffs standardized Interval 30.4 to 49.8	41.2 cumulative number of puffs standardized Interval 32.1 to 50.2

OTHER_PRE_SPECIFIED outcome

Timeframe: During an URTI or flare-up during the 7-month follow-up period

Group difference in the severity on the asthma symptoms documented as the sum of daily score on the 'Asthma FLare-up DIary for Young Children' questionnaire where best =1, worst = 7 on each day during asthma flare-up. Since the flare-up typically lasts several days, the cumulative daily score, standarized over 7 days (total possible scale range: 7-49), may increase due to severity or due to the duration of the event. Lower scores indicate lowest severity, higher score indicate longer or higher severity of symptoms.

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Severity of Asthma Symptoms During an Asthma Flare-up (Cumulative Daily Score Standardized Over 7 Days)	11.0 score on a ADYC scale Interval 8.9 to 13.2	12.5 score on a ADYC scale Interval 9.8 to 15.1

OTHER_PRE_SPECIFIED outcome

Timeframe: During an URTI or flare-up during the 7-month follow-up period

Group difference in the duration of asthma symptoms documented on the 'Asthma FLare-up DIary for Young Children' questionnaire

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Duration of Asthma Symptoms During a Flare-up (by Diary)	5.1 days/exacerbation Interval 3.1 to 7.0	5.2 days/exacerbation Interval 4.2 to 6.2

OTHER_PRE_SPECIFIED outcome

Timeframe: During the 7-month follow-up period

The number of asthma exacerbations requiring rescue oral corticosteroids per child

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Number of Asthma Exacerbations/Child	0.96 Courses of oral steroids/child Interval 0.63 to 1.45	0.79 Courses of oral steroids/child Interval 0.51 to 1.24

OTHER_PRE_SPECIFIED outcome

Timeframe: During an URTI or flare-up during the 7-month follow-up period

Group difference in the caregivers' functional status measured on the 'Effect of a child's asthma flare-up on parents' (ECAP) questionnaire (best =7, worst = 1)

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Impact of Exacerbations on Caregivers' Functional Status	3.3 Score of a scale Interval 2.8 to 3.9	3.2 Score of a scale Interval 2.6 to 3.8

OTHER_PRE_SPECIFIED outcome

Timeframe: During an URTI or flare-up during the 7-month follow-up period

Mean group difference in the caregivers' number of workdays lost per exacerbation, reported in number of days per flare-up

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Caregivers' Workday Lost (in Days Per Flare-up)	1.0 days per flare-up Interval 0.3 to 1.7	1.7 days per flare-up Interval 0.9 to 2.5

OTHER_PRE_SPECIFIED outcome

Timeframe: During the 7-month follow-up period

The percentage of participants with ≥1 reported asthma exacerbations requiring rescue oral corticosteroids

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Percent of Participants With at Least 1 Exacerbation Requiring Rescue Oral Corticosteroids	61 percentage of participants	42 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During an URTI or flare-up during the 7-month follow-up period

Group difference in the duration of asthma symptoms by verbal report.

Outcome measures

Measure	Vitamin D n=23 Participants Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter	Placebo n=24 Participants 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
Duration of Asthma Symptoms During a Flare-up (Verbal Report)	7.6 days/exacerbation Interval 5.1 to 10.0	7.4 days/exacerbation Interval 5.8 to 9.0

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Vitamin D

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=24 participants at risk 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter	Vitamin D n=23 participants at risk Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter
Respiratory, thoracic and mediastinal disorders peribronchitis	4.2% 1/24 • Number of events 1	0.00% 0/23

Other adverse events

Measure	Placebo n=24 participants at risk 2 ml identical placebo taken by mouth at baseline and 3.5 months. placebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter	Vitamin D n=23 participants at risk Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months. vitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter
General disorders General (SOC)	70.8% 17/24 • Number of events 29	56.5% 13/23 • Number of events 18
Infections and infestations infections and infestations (SOC)	70.8% 17/24 • Number of events 49	82.6% 19/23 • Number of events 39
Respiratory, thoracic and mediastinal disorders Respiratory (SOC)	29.2% 7/24 • Number of events 7	17.4% 4/23 • Number of events 4
Blood and lymphatic system disorders Blood and lymphatic system disorders (SOC)	4.2% 1/24 • Number of events 1	13.0% 3/23 • Number of events 3
Ear and labyrinth disorders Ear and labyrinth disorders (SOC)	8.3% 2/24 • Number of events 2	0.00% 0/23
Eye disorders Eye disorders (SOC)	4.2% 1/24 • Number of events 1	0.00% 0/23
Gastrointestinal disorders Gastrointestinal disorders (SOC)	33.3% 8/24 • Number of events 11	13.0% 3/23 • Number of events 4
Immune system disorders Immune system disorders (SOC)	20.8% 5/24 • Number of events 6	8.7% 2/23 • Number of events 3
Investigations Investigations (SOC)	37.5% 9/24 • Number of events 16	30.4% 7/23 • Number of events 12
Musculoskeletal and connective tissue disorders Musculoskeletal disorders (SOC)	4.2% 1/24 • Number of events 1	0.00% 0/23
Nervous system disorders Nervous system disorder (SOC)	4.2% 1/24 • Number of events 1	4.3% 1/23 • Number of events 1
Reproductive system and breast disorders Reproductive system (SOC)	0.00% 0/24	4.3% 1/23 • Number of events 1
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders (SOC)	16.7% 4/24 • Number of events 5	30.4% 7/23 • Number of events 10
Surgical and medical procedures Surgical and medical procedures (SOC)	4.2% 1/24 • Number of events 1	4.3% 1/23 • Number of events 1

Additional Information

Dr Francine Ducharme

StJustineH

Phone: 5143454931

Email: Francine.m.ducharme@umontreal.ca

Results disclosure agreements

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