Trials / Completed
CompletedNCT01698840
Effect of Vitamin D in Diets of Preterm Infants
An Evaluation of the Effects of Two Levels of Vitamin D in Infants Fed Preterm or Transitional Formula on Serum 25-Hydroxyvitamin D and Bone Status in Preterm Infants: A Double-Blind, Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Baylor College of Medicine · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation at birth. However, few data are available related to follow-up of infants receiving these formulas who were 28-34 weeks gestation at birth. Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Vitamin D | |
| DIETARY_SUPPLEMENT | Placebo |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2016-07-30
- Completion
- 2016-07-30
- First posted
- 2012-10-03
- Last updated
- 2026-01-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01698840. Inclusion in this directory is not an endorsement.