Vitamin D Supplementation RCT in Infants with RS Viral Infection for Preventing Recurrent Wheeze

JRCT ID: jRCTs031200376

Registered date:26/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: RS viral infection
• Date of first enrollment: 07/06/2021
• Target sample size: 140
• Study type: Interventional

Intervention(s)

Vitamin D3 (Cholecalciferol)

lt 3.0kg: (exclusion criteria)
[3.0-6.0) kg: 500IU
[6.0-8.5) kg: 750 IU
[8.5-11.5) kg: 1000 IU
[11.5 kg: 1250 IU

or Placebo

Outcome(s)

• Primary Outcome: Prevalance of wheezing for 12 months after entry.

Secondary Outcome

Duration of administration
Intubation management, intensive care, and death after admission
Days of oxygen use during hospitalization
Number of days until oral intake can be started
Serum 25-(OH)D and Ca concentration before and 2 weeks after treatment
Number/Timing of wheezing for 12 months after entry
Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 2month old
• Age maximum: <= 3age old
• Gender: Both

Include criteria

(1) Rapid antigen testing or PCR for the respiratory syncytial virus is positive
(2) Patients between 2 months and 36 months old.
(3) Parents or guardians have given consent to participate in this study

Exclude criteria

(1) If the patient weighs less than 3 kg at the time of admission
(2) When palivizumab (Synagis) is being administered or is indicated for administration
(3) Comorbidities such as chromosomal abnormalities or respiratory diseases which may affect the course of RS virus infection.
(4) Cases requiring ventilatory management at the time of admission
(5) Use of a vitamin D product (either prescription or supplement) from birth to the time of registration
(6) If the principal investigator or research co-investigator determines that participation is inappropriate

Related Information

• Primary Sponsor: Takahashi Kyohei
• Source(s) of Monetary Support: National Hospital Organization