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

Vitamin D Supplementation in Infants with RS Viral Infection for Preventing Recurrent Wheeze: A Randomized, Double-Blind, Placebo-Controlled Study - RSVD

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200376
Enrollment
140
Registered
2021-02-26
Start date
2021-06-07
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

RS viral infection

Interventions

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
D002762

Sponsors

Takahashi Kyohei
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Prevalance of wheezing for 12 months after entry.

Secondary

MeasureTime frame
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

Contacts

Public ContactKyohei Takahashi

National Hospital Organization Sagamihara National Hospital

kcrt@kcrt.net+81-42-742-8311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026