Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life (VitDBR2012)
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| ClinicalTrials.gov Identifier: NCT01875757 |
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Recruitment Status :
Completed
First Posted : June 12, 2013
Last Update Posted : March 22, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Bronchitis Upper Respiratory Tract Infection Acute Bronchiolitis | Drug: Vitamin D3 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life |
| Study Start Date : | November 2013 |
| Actual Primary Completion Date : | December 2016 |
| Actual Study Completion Date : | December 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vitamin D3 1000 IU/day
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
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Drug: Vitamin D3 Drug: Placebo |
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Active Comparator: Vitamin D3 400 IU/day
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
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Drug: Vitamin D3 Drug: Placebo |
- Percentage of children with acute bronchitis [ Time Frame: 1 year ]Check that the administration of a vitamin D dose of 1,000 U / day decreases the percentage of children with acute bronchitis during the first year of life
- Number of episodes of upper respiratory infections reported by parents in the first year of life [ Time Frame: 1 year ]Check that the supplementation of vitamin D of 1,000 units / day decreases the number of upper respiratory infections
- Percentage of children with recurrent bronchitis [ Time Frame: 1 year ]Check that the supplementation of vitamin D of 1,000 units / day decreases the number of recurrent bronchitis
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| Ages Eligible for Study: | up to 19 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875757
| Spain | |
| Hospital Universitary Vall d'Hebron | |
| Barcelona, Spain, 08035 | |
| Study Chair: | Antonio Moreno, MD, PhD | Hospital Universitari Vall d'hebron Barcelona, Spain |
| Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
| ClinicalTrials.gov Identifier: | NCT01875757 |
| Other Study ID Numbers: |
2012-001152-19 2012-001152-19 ( EudraCT Number ) |
| First Posted: | June 12, 2013 Key Record Dates |
| Last Update Posted: | March 22, 2017 |
| Last Verified: | March 2017 |
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Vitamin D Acute bronchitis Upper respiratory tract infection |
Recurrent bronchitis Acute bronchiolitis Infants |
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Respiratory Tract Infections Infections Respiratory Tract Diseases Bronchiolitis Bronchitis Acute Disease Bronchial Diseases Lung Diseases, Obstructive Lung Diseases |
Disease Attributes Pathologic Processes Vitamin D Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |