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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02941185 |
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Date of registration:
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18/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multi-dose Vitamin D Supplementation in Preterm Infants
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Scientific title:
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Date of first enrolment:
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January 2014 |
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Target sample size:
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121 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02941185 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Preterm infants with gestational age 24 to 32 weeks who achieved at least 75% of total
nutrition by enteral feedings in postnatal 2 weeks
Exclusion Criteria:
- perinatal asphyxia,
- major congenital or chromosomal anomalies,
- those with no expectation of survival in first 2 weeks
- those that total parenteral nutrition was not ceased by the first 2 weeks
Age minimum:
24 Weeks
Age maximum:
32 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Vitamin D Deficiency
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Preterm Infants
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Intervention(s)
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Drug: Devit-3 Oral Drop
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Primary Outcome(s)
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Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.
[Time Frame: 36 weeks]
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Serum concentration of 25(OH) D at 36 weeks postmenstrual age.
[Time Frame: 36 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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