Vitamin D to Reduce Colds and Asthma Attacks in Young Children

NCT01999907 | Completed Phase 2 DMC

• 2 other identifiers: VD000112140
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

asthma; virus diseases; pediatric; RCT; steroid

Outcome Measures

Primary Outcomes (1)

• serum Vitamin D

  mean change in serum vitamin D from baseline to 3 months

  3 months

Secondary Outcomes (1)

• adequate serum vitamin D

  3 months

Other Outcomes (9)

• exacerbations requiring oral corticosteroids

  6 months

• number of viral infections

  6 months

• Hypercalciuria

  any point during the 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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).

Dietary Supplement: daily vitamin D supplement; Other: Placebo

Vitamin D

ACTIVE COMPARATOR

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).

Dietary Supplement: Vitamin D; Dietary Supplement: daily vitamin D supplement

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

Also known as: cholecalciferol

Vitamin D

daily vitamin D supplement DIETARY_SUPPLEMENT

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

Also known as: cholecalciferol (Pediavit)

Placebo; Vitamin D

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (2)

• 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.

  PMID: 33305842 DERIVED

• 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.

  PMID: 27456232 DERIVED

MeSH Terms

Conditions

Asthma; Virus Diseases

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Infections

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Francine M Ducharme

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Pediatrician

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 12, 2015

Record last verified: 2015-01

Locations

CA (1)