Effect of Vitamin D in Diets of Preterm Infants (NCT01698840) | Clinical Trial Compass
CompletedNot Applicable
Effect of Vitamin D in Diets of Preterm Infants
United States39 participantsStarted 2013-01
Plain-language 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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Born at 28 0/7 to 34 6/7 weeks PMA and 1000-2250 g birth weight.
* Currently 34 0/7 to 38 6/7 weeks post-menstrual age at time of consent.
* Born at Texas Children's (including Pavilion for Women) or Methodist campus hospitals or transferred within 48 hours of birth.
* Care expected to be provided at one of these institutions until discharge home.
* Any initial feeding will be permitted, but expected to transition to primarily (80% of feeds or up to 2 breast milk feeds per day) infant formula by 38 6/7 weeks PMA or hospital discharge, whichever comes first.
* Able to tolerate 22 kcal/oz transitional formula and receive a volume of at least 130 mL/kg/day total feeding volume.
* No longer receiving any form of mechanical ventilation or diuretics. Low flow nasal cannula (\< ¼ LPM) will be permitted if it is anticipated this will be discontinued before hospital discharge.
Exclusion Criteria:
* Bronchopulmonary dysplasia (BPD) requiring daily use of diuretics beyond 38 6/7 weeks PMA (or hospital discharge, whichever comes first) and \> 22 kcal/oz concentration formula beyond 38 6/7 weeks PMA.
* Major congenital anomalies, history of proven Stage 2 or above NEC, or severe feeding intolerance.
* Caloric density greater than 22 kcal/oz.
* Higher order multiples (However, twins are acceptable. Twins will be randomized together. Only data from 1 twin picked at random will be used in the final analyses.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Serum 25-hydroxyvitamin D (25-OHD) level at 52 weeks post-menstrual age
Timeframe: Last 7 days of hospitalization and at 52 weeks post-menstrual age (PMA)