Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial

NCT01284907 | Withdrawn DMC

• 1 other identifier: AAMDHREC NO: 09/58
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma

Conditions

Asthma

Keywords

Asthma; Asthma therapy; Randomized controlled trial; children

Outcome Measures

Primary Outcomes (1)

• A change from baseline in Peak expiratory flow rate

  up to six months

Secondary Outcomes (1)

• A change from baseline in lung function test

  up to six months

Study Arms (2)

Vit D

ACTIVE COMPARATOR

Dietary Supplement: Vitamin D3 (Cholecalciferol)

Placebo drops

PLACEBO COMPARATOR

Dietary Supplement: Placebo Drops

Interventions

Vitamin D3 (Cholecalciferol) DIETARY_SUPPLEMENT

Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months

Also known as: Cholecalciferol

Vit D

Placebo Drops DIETARY_SUPPLEMENT

Placebo drops

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Physician diagnosed asthmatics and they should fulfill at least two of the following three criteria:
• A minimum of three clinic visits for acute asthma within 1 year
• Two or more asthma-related hospital admissions within 1 year, or
• Steroid dependency, as defined by either 6 months of oral or 1 year of inhaled corticosteroid use
• Age: 6-14 years old. The age group of 6 to 14 years old was chosen for two reasons:
• Diagnostic accuracy of asthma is better in this age group as non-specific wheezers less than 6 years of age could be excluded.
• Child should be able to use a peak flow meter and perform spirometry tests.
• A positive specific IgE or a positive skin prick test for at least one airborne allergen.

You may not qualify if:

• Children with mild intermittent and mild persistent asthma.
• Asthmatic children who are currently on immunotherapy or anti IgE.
• Asthmatic children with concomitant other medical problems.
• Children who are younger than 6 yrs or older than 14 yrs.
• Children with history of early life injury to airways like premature birth (\< 36 weeks) or home use of oxygen.
• Children with vitamin D deficiency. Since these children may be randomized to the control group, they will be excluded for ethical reasons.

Sponsors & Collaborators

• United Arab Emirates University: lead
• Roma Paediatrics: collaborator

Study Sites (2)

Tawam Hospital

Al Ain City, P. O. Box: 15258, United Arab Emirates

Location

Al Ain Hospital

Al Ain City, P.O.Box: 1006, United Arab Emirates

Location

MeSH Terms

Conditions

Asthma

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mariam Elremeli, MD

  Roma Paediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 27, 2011
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 17, 2014

Record last verified: 2014-12

Locations

AE (2)