Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life (VitDBR2012)

Vall d'Hebron University Hospital (HUVH)

Status and phase: Completed; Phase 3

Conditions: Acute Bronchitis; Acute Bronchiolitis; Upper Respiratory Tract Infection

Treatments: Drug: Vitamin D3; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01875757

2012-001152-19 (EudraCT Number)

Details and patient eligibility

About

A phase III multicenter randomized double blind clinical trial will be conducted. After obtaining written consent the infant will be randomized, during the first two weeks of life, to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.

Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric measurements and a questionnaire about health issues. A blood sample will be obtained at baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH vitamin D, and calcium.

Healthy term born infants of appropriate size for gestational age will be included. We will need to include 359 children in each group.

The primary objective of the study is to decrease the proportion of infants with acute bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D. Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases the proportion of infants with upper respiratory tract infections, the proportion of children under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare system due to respiratory infections and absences from work for parents and achieves a higher proportion of children with adequate blood levels 25 OH vitamin D.

Enrollment: 200 patients

Sex: All

Ages: Under 19 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy term born infants of appropriate size for gestational age
• Parents provide informed consent to participate

Exclusion criteria

• Infants with small size for gestational age
• Infants with gestational age < 37 weeks
• Infants with congenital anomalies
• Infants with chronic gastrointestinal tract, liver, kidney, heart, or neurological diseases
• Infants with disorders of vitamin D or calcium metabolism or others inborn errors of metabolism

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Vitamin D3 1000 IU/day

Experimental group

Description:

Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 1.000 IU/day during the first year of life, taking into account the vitamin D received with artificial milk

Treatment:

Drug: Placebo

Drug: Vitamin D3

Vitamin D3 400 IU/day

Active Comparator group

Description:

Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 400 IU/day during the first year of life, taking into account the vitamin D received with artificial milk

Treatment:

Drug: Placebo

Drug: Vitamin D3