Efficacy and safety of vitamin D supplementation in asthmatic children: a randomized controlled trial (ESDAC trial)

Efficacy and safety of vitamin D supplementation in asthmatic children who are vitamin D deficient: a randomized controlled trial (ESDAC trial) - ESDAC trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/09/006214

Enrollment

250

Registered

2015-09-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Persistent asthma

Interventions

Intervention1: Vitamin D: Vitamin D 1000 IU /day in liquid form single daily dose preferably on same time of day for nine months Control Intervention1: Placebo: Placebo will be administrated in same v

Eligibility

Inclusion criteria

Inclusion criteria: 1) Children 4 to 12 years of age. 2) Physician diagnosed persistent asthma receiving regular inhaled corticosteroids. All (mild, moderate, and severe) persistent asthma receiving any dose of inhaled steroids will be eligible for study. Both old and new cases of persistent asthma and all types (atopic, non-atopic) of persistent asthma will be included for study. (3) Vitamin D levels < 20 ng/ml

Exclusion criteria

Exclusion criteria: 1) Clinically having rickets. 2) Children with chronic diseases like chronic renal failure, chronic liver disease, or any bone disease. 3) Mental retardation. 4) Receiving vitamin D supplementation. 5) Received a mega dose of vitamin D (3 lac-6 lac units) in last one month. 6) Any patient that in the opinion of investigators is unlikely to follow up. 7) Participation in any other clinical trial within 3 months prior to enrolment 8) Parents not giving consent.

Design outcomes

Primary

Measure	Time frame
1. Proportion of children having Childhood Asthma Control Test score 20 or more at end of the treatment. 2. Adverse effects.Timepoint: At nine months	—

Secondary

Measure	Time frame
Change in forced expiratory volume in first second (FEV1), FVC/FEV1, and PEFR by from baseline to end of the treatmentTimepoint: At nine months;Change in mean CACT score from baseline to end of the treatmentTimepoint: at nine months;Change in vitamin D levelsTimepoint: At nine months;Height gain from enrollment to final follow-upTimepoint: At nine months;Number of courses of oral steroids useTimepoint: Throughout study;Number of days requiring rescue medications and number of night awakeningsTimepoint: Throughout study;Number of emergency visitsTimepoint: Throughout study;Proportion of children having CACT score 20 or more at end of follow upTimepoint: At nine months;Total dose of inhaled steroidsTimepoint: Throughout study	—

Measure

Time frame

Change in forced expiratory volume in first second (FEV1), FVC/FEV1, and PEFR by from baseline to end of the treatmentTimepoint: At nine months;Change in mean CACT score from baseline to end of the treatmentTimepoint: at nine months;Change in vitamin D levelsTimepoint: At nine months;Height gain from enrollment to final follow-upTimepoint: At nine months;Number of courses of oral steroids useTimepoint: Throughout study;Number of days requiring rescue medications and number of night awakeningsTimepoint: Throughout study;Number of emergency visitsTimepoint: Throughout study;Proportion of children having CACT score 20 or more at end of follow upTimepoint: At nine months;Total dose of inhaled steroidsTimepoint: Throughout study

—

Countries

India

Contacts

Public ContactDR KANA RAM JAT

All India Institute of Medical Sciences, New Delhi

drkanaram@gmail.com9868152426

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026