Vitamin D to Reduce Colds and Asthma Attacks in Young Children (DIVA-pilot)

St. Justine's Hospital

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Other: Placebo; Dietary Supplement: Vitamin D; Dietary Supplement: daily vitamin D supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01999907

12140 (Other Grant/Funding Number)

VD0001

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: daily vitamin D supplement

Other: Placebo

Vitamin D

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: daily vitamin D supplement

Dietary Supplement: Vitamin D