Vitamin D Supplementation for Premature Infants
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Disqualifiers: Congenital anomaly, Nonbacterial infection, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What data supports the effectiveness of the drug 800 IU/day vitamin D supplementation for premature infants?
Research shows that early supplementation with 800 IU of vitamin D is effective and safe for very low birth weight infants, helping to improve their vitamin D levels. Another study found that even lower doses of vitamin D (500 IU) increased vitamin D levels in premature infants, suggesting that 800 IU could be even more effective.
12345Is vitamin D supplementation safe for premature infants?
Vitamin D supplementation in premature infants is generally safe, but it should be monitored to avoid overdose. Some studies have shown that high doses can lead to potentially toxic levels, so careful monitoring is important to ensure safety.
12678How does the drug Vitamin D3 supplementation for premature infants differ from other treatments?
The 800 IU/day vitamin D3 supplementation for premature infants is unique because it provides a higher dose than typically recommended, aiming to better support bone health and overall development in the first 28 days after birth, while the standard dose often ranges from 400 to 960 IU/day.
910111213Eligibility Criteria
This trial is for very premature infants born at less than 28 weeks or weighing under 1000 grams. It's not for babies with conditions affecting vitamin D absorption, like cystic fibrosis, those too sick where intensive care isn't justified, with congenital infections, over 32 weeks gestation, or with major birth defects.Inclusion Criteria
My condition is congenital.
Informed written consent in an Institutional Review Board (IRB)-approved manner
My baby was born before 28 weeks or weighed less than 1000 grams.
Exclusion Criteria
Any major congenital anomaly
Any known congenital nonbacterial infection
Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Infants receive either vitamin D supplementation or placebo for the first 28 days after birth
4 weeks
Daily administration
Follow-up
Participants are monitored for growth, neurodevelopment, and respiratory outcomes
2 years
Extended Follow-up
Monitoring of respiratory support and neurodevelopmental outcomes
22 to 26 months corrected age
Participant Groups
The study tests if giving a high dose of vitamin D (800 IU/day) to extremely premature babies helps their bones, lungs, immune system and brain compared to usual care. Babies are randomly given either the vitamin D supplement or no extra vitamins in their first month.
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual care plus vitamin D supplementationExperimental Treatment2 Interventions
Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day. At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.
Group II: Usual care plus placeboActive Control2 Interventions
Infants will receive placebo (normal saline) in the first 28 days after birth. Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices.
800 IU/day vitamin D supplementation with feedings in the first 28 days after birth is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Cholecalciferol for:
- Prevention and treatment of vitamin D deficiency
- Rickets
- Osteomalacia
🇺🇸 Approved in United States as Vitamin D3 for:
- Prevention and treatment of vitamin D deficiency
- Rickets
- Osteomalacia
🇨🇦 Approved in Canada as Cholecalciferol for:
- Prevention and treatment of vitamin D deficiency
- Rickets
- Osteomalacia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Medical BranchGalveston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
References
Efficacy and safety of early supplementation with 800 IU of vitamin D in very preterm infants followed by underlying levels of vitamin D at birth. [2022]To determine the efficacy and safety of early supplementation with 800 IU of vitamin D in very low birth weight (VLBW) infants.
Vitamin D nutritional status of premature infants supplemented with 500 IU vitamin D2 per day. [2019]The vitamin D nutritional status of premature infants was assessed by determining plasma 25-hydroxyvitamin D concentrations before and during supplementation with 500 IU vitamin D2 per day. Fifty-one samples were collected from 25 healthy infants fed breast milk and a vitamin D3 fortified formula. Gestational age was 32.2 +/- 2.4 weeks (mean +/- 1 SD). 25-hydroxyvitamin D levels before supplementation correlated well with maternal values (r = 0.81). The infants' mean plasma concentration increased from 30.6 +/- 13.7 nmol/l (mean +/- 1 SD) after birth to 46.3 +/- 10.5 nmol/l after 9 +/- 1 days (p less than 0.0025), and to 65.3 +/- 16.6 nmol/l after 37 +/- 10 days of vitamin D2 treatment (p less than 0.0005). 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 were determined separately, and it appeared that the rise was accounted for by the D2 fraction while 25-hydroxyvitamin D3 concentrations were unchanged. The results demonstrate that vitamin D2 is well absorbed and hydroxylated in the 25 position by premature infants free of associated disease, and that a supplementation of 500 IU per day in addition to breast milk and a regular vitamin D fortified formula is adequate to rapidly establish 25-hydroxyvitamin D levels within the normal adult range.
Vitamin D status and adequacy of standard supplementation in preterm neonates from South India. [2018]The aim of this study was to assess vitamin D status of preterm babies at birth and adequacy of daily supplementation with vitamin D.
A randomized double-blind controlled trial comparing two regimens of vitamin D supplementation in preterm neonates. [2022]To compare the efficacy of 400 vs 1000 IU oral vitamin D supplementation in preterm neonates of 27 to 34 weeks gestation.
Vitamin D status in very low birth weight infants and response to vitamin D intake during their NICU stays: a prospective cohort study. [2022]To evaluate vitamin D status in very low birth weight (VLBW) infants and response to vitamin D intake.
Monitored Supplementation of Vitamin D in Preterm Infants: A Randomized Controlled Trial. [2021]Appropriate supplementation of vitamin D can affect infections, allergy, and mental and behavioral development. This study aimed to assess the effectiveness of monitored vitamin D supplementation in a population of preterm infants. 109 preterm infants (24 0/7-32 6/7 weeks of gestation) were randomized to receive 500 IU vitamin D standard therapy (n = 55; approximately 800-1000 IU from combined sources) or monitored therapy (n = 54; with an option of dose modification). 25-hydroxyvitamin D [25(OH)D] concentrations were measured at birth, 4 weeks of age, and 35, 40, and 52 ± 2 weeks of post-conceptional age (PCA). Vitamin D supplementation was discontinued in 23% of infants subjected to standard treatment due to increased potentially toxic 25(OH)D concentrations (>90 ng/mL) at 40 weeks of PCA. A significantly higher infants' percentage in the monitored group had safe vitamin D levels (20-80 ng/mL) at 52 weeks of PCA (p = 0.017). We observed increased vitamin D levels and abnormal ultrasound findings in five infants. Biochemical markers of vitamin D toxicity were observed in two patients at 52 weeks of PCA in the control group. Inadequate and excessive amounts of vitamin D can lead to serious health problems. Supplementation with 800-1000 IU of vitamin D prevents deficiency and should be monitored to avoid overdose.
Vitamin D in Preterm and Full-Term Infants. [2021]Vitamin D is necessary for the active (transcellular) absorption of calcium and for skeletal health. Inadequate vitamin D in infants leads to increased risks of poor bone mineralization and ultimately rickets. Rickets is uncommon in full-term infants with a much higher risk in very premature infants. However, the primary cause of rickets in premature infants is a deficiency of calcium and phosphorus, not vitamin D. Available research, as well as most guidelines, recommend an intake of 400 IU daily of vitamin D as adequate for bone health in preterm and full-term infants. Higher doses have not been consistently shown to have specific clinical benefits for healthy infants. There are no strong data to support either routine testing of serum 25-hydroxyvitamin D or targeting high serum 25-hydroxyvitamin D levels (e.g., 30 ng/mL) in healthy preterm or full-term infants. Vitamin D is commonly provided to infants via drops for breastfed babies or via infant formula, although alternative dosing approaches exist for breastfed infants, which some families may prefer. These include the use of drops placed on the mother's breast, dissolvable doses, and high maternal doses (approximately 6,400 IU daily). Infant formula contains vitamin D, and most infants will reach an intake from formula of about 400 IU daily within the first 2 months of life if they are consuming routine cow milk-based formula. Although vitamin D toxicity is very uncommon, caution should be used to avoid extremely concentrated high doses found in some commercially available drops. Infants with liver or kidney disease may need special attention to vitamin D intake and status. Further research is needed to define the role of vitamin D in non-bone health outcomes of infants and to identify methods to enhance compliance with current recommendations for vitamin D intake in infants.
Vitamin D and mineral metabolism in the very low birth weight infant receiving 400 IU of vitamin D. [2019]To examine (1) the effect of vitamin D intake (380 to 480 IU daily) on plasma 25-hydroxyvitamin D (25-OHD) and 1,25-dihydroxyvitamin D (1,25-(OH)2D) concentrations and (2) the relationship of 1,25-(OH)2D to calcium and phosphorus absorption and retention in the very low birth weight infant receiving a preterm infant formula.
Randomized trial of two doses of vitamin D3 in preterm infants [2018]Recommendations for vitamin D supplementation for preterm infants span a wide range of doses. Response to vitamin D supplementation and impact on outcomes in preterm infants is not well understood.
Serum 25 Hydroxy Vitamin D Levels in Very Low Birth Weight Infants Receiving Oral Vitamin D Supplementation. [2019]Vitamin D supplementation in preterm infants has been recommended by American Academy of Pediatrics (AAP); however, its efficacy and safety has not been well studied. To study 25-hydroxy vitamin D (25OHD) levels as a marker of vitamin D status of very low birth weight infants while on vitamin D supplementation during neonatal intensive care unit hospitalization.
Vitamin D Intake in Very Low Birth Weight Infants in Neonatal Intensive Care Unit. [2018]It is unknown how often preterm infants in neonatal intensive care units achieve the American Academy of Pediatrics-recommended daily intake of 400 international units of Vitamin D. We studied 378 preterm infants with birth weight 1500 g or less admitted to our neonatal intensive care unit, 151 infants before and 227 infants after daily vitamin D-intake monitoring was introduced. Infants were stratified into 2 groups: extremely low birth weight (
Randomised controlled trial of vitamin D supplementation on bone density and biochemical indices in preterm infants. [2019]To test the hypothesis that a vitamin D dose of 200 IU/kg, maximum 400 IU/day, given to preterm infants will maintain normal vitamin D status and will result in as high a bone mineral density as that attained with the recommended dose of 960 IU/day.
Plasma 1.25-dihydroxyvitamin D concentrations in preterm infants. [2019]1.25-Dihydroxyvitamin D concentrations were measured in 10 preterm infants (mean gestational age 29 weeks, range 26-32; mean birthweight 1226 g, range 980-1700). Total parenteral nutrition was begun after birth and partial enteral feeding was started at 1 week of age. Total enteral feeding was achieved at a mean age of 26 days (range 16-47). The daily vitamin D3 intake was about 400 I. U. No clinical, chemical or radiological signs of rickets were observed. The mean 1.25-dihydroxyvitamin D concentration +/- SEM was 103.2 +/- 24.0 pmol/l at 1 week (range 9.6-252.0), 141.6 +/- 26.4 at 3 weeks (range 31.2-324.0), 153.6 +/- 21.6 at 6 weeks (range 67.2- 256.8), 165.6 +/- 24.0 at 9 weeks (range 74.4-307.2) and 153.6 +/- 21.6 at 12 weeks (range 76.8-268.8) postnatal age. The mean values at 6, 9 and 12 weeks were significantly higher (p resp. less than 0.01, less than 0.002 and less than 0.005) than in adults (88.8 +/- 7.2; n = 27). 1.25-Dihydroxyvitamin D concentrations were highly variable and did not correlate with 25-hydroxyvitamin D concentrations, plasma calcium and phosphorus concentrations and plasma alkaline phosphatase levels, nor with illness nor postnatal age. The data demonstrate that preterm infants are capable of producing high plasma levels of 1.25-dihydroxyvitamin D.