Vitamin D to Reduce Colds and Asthma Attacks in Young Children

NCT ID: NCT01999907

Last Updated: 2015-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-08-31

Brief Summary

Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

bolus placebo given in a 2ml dose by mouth at baseline. This group receives daily vitamin D supplement by mouth for the 6 month study (400IU cholecalciferol per day).

Group Type: PLACEBO_COMPARATOR

daily vitamin D supplement

Intervention Type: DIETARY_SUPPLEMENT

Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day.

Placebo

Intervention Type: OTHER

placebo given in a 2ml dose by mouth at baseline.

Vitamin D

Vitamin D (100,000IU) bolus in a 2ml dose by mouth given at baseline. This group receives a daily vitamin D supplement by mouth for 6 months (400IU cholecalciferol per day).

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

100,000IU cholecalciferol given in a 2ml dose by mouth at baseline.

daily vitamin D supplement

Intervention Type: DIETARY_SUPPLEMENT

Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day.

Interventions

Vitamin D

100,000IU cholecalciferol given in a 2ml dose by mouth at baseline.

Intervention Type: DIETARY_SUPPLEMENT

daily vitamin D supplement

Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

placebo given in a 2ml dose by mouth at baseline.

Intervention Type: OTHER

Other Intervention Names

cholecalciferol; cholecalciferol (Pediavit)

Eligibility Criteria

Inclusion Criteria

• children aged 1-5 years
• physician-diagnosed asthma as per GINA guidelines
• upper respiratory tract infections as the main asthma exacerbation trigger
• ≥4 respiratory infections in the past 12 months
• ≥1 exacerbation requiring rescue oral steroids in the past 6 months or ≥2 in the previous 12 months.

Exclusion Criteria

• extreme prematurity (<28 weeks gestation)
• infants <12 months of age
• breastfed infants with no vitamin D supplementation
• recent (<1 year) immigrants from countries where rickets and malnutrition prevalent
• other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)
• endocrine disorder of calcium/ vitamin D metabolism
• disorder/ disease with associated malabsorption (inflammatory bowel disease)
• kidney/ liver disease
• sickle cell anemia
• medications known to interfere with bone metabolism/ vitamin D levels
• vitamin D supplementation >1000 IU/ day in past 3 months
• unable to attend medical visit in 3-4 months
• plan to leave the province during the next 6 months.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Professor Francine Ducharme

Professor & Pediatrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francine M Ducharme

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

CHU Sainte-Justine

Montreal, Quebec, Canada

Countries

Canada

References

Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

Reference Type: DERIVED

PMID: 33305842 (View on PubMed)

Jensen ME, Mailhot G, Alos N, Rousseau E, White JH, Khamessan A, Ducharme FM. Vitamin D intervention in preschoolers with viral-induced asthma (DIVA): a pilot randomised controlled trial. Trials. 2016 Jul 26;17(1):353. doi: 10.1186/s13063-016-1483-1.

Reference Type: DERIVED

PMID: 27456232 (View on PubMed)

Other Identifiers

12140

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VD0001

Identifier Type: -

Identifier Source: org_study_id