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A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial
Prem Fort1, Ariel A Salas1, Teodora Nicola1
1Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.
Insights
Extremely preterm infants often have vitamin D deficiency at birth. Supplementation with 200 IU/d improved vitamin D levels, while 800 IU/d prevented deficiency by day 28, though clinical outcomes did not differ.
Area of Science:
- Neonatology
- Pediatric Endocrinology
- Nutritional Science
Background:
- Extremely low gestational age newborns frequently present with biochemical vitamin D deficiency at birth.
- Vitamin D sufficiency is crucial for infant health and development.
- Optimal dosing strategies for vitamin D supplementation in this vulnerable population remain under investigation.
Purpose of the Study:
- To ascertain the most effective dose of vitamin D supplementation required to achieve biochemical vitamin D sufficiency in extremely preterm infants.
- To evaluate the impact of different vitamin D doses on serum 25-hydroxy vitamin D concentrations and clinical outcomes.
Main Methods:
- A masked randomized controlled trial involving 100 infants born between 23 0/7 and 27 6/7 weeks gestation.
- Infants were assigned to receive either placebo, 200 IU/d, or 800 IU/d of vitamin D, considering background nutritional support.
- Primary outcomes included serum 25-hydroxy vitamin D levels on day 28 and days alive and off respiratory support.
Main Results:
- At birth, 67% of infants exhibited vitamin D deficiency (serum 25-hydroxy vitamin D <20 ng/mL).
- On day 28, median vitamin D levels were 22 ng/mL (placebo), 39 ng/mL (200 IU), and 84.5 ng/mL (800 IU) (P < .001).
- No significant differences were observed in days alive and off respiratory support across the groups (P = .63).
Conclusions:
- Vitamin D deficiency is prevalent at birth in extremely preterm infants.
- Supplementation with 200 IU/d improves biochemical status, while 800 IU/d prevents deficiency by day 28.
- Further research is needed to determine if correcting biochemical deficiency translates to improved clinical outcomes.
Objective:
To determine the optimal dose of vitamin D supplementation to achieve biochemical vitamin D sufficiency in extremely low gestational age newborns in a masked randomized controlled trial.
Study Design:
100 infants 23 0/7-27 6/7 weeks gestation were randomized to vitamin D intakes of placebo (n = 36), 200 IU (n = 34), and 800 IU/d (n = 30) (approximating 200, 400, or 1000 IU/d, respectively, when vitamin D routinely included in parenteral or enteral nutrition is included). The primary outcomes were serum 25-hydroxy vitamin D concentrations on postnatal day 28 and the number of days alive and off respiratory support in the first 28 days.
Results:
At birth, 67% of infants had 25-hydroxy vitamin D <20 ng/mL suggesting biochemical vitamin D deficiency. Vitamin D concentrations on day 28 were (median [25th-75th percentiles], ng/mL): placebo: 22 (13-47), 200 IU: 39 (26-57), 800 IU: 84.5 (52-99); P < .001. There were no differences in days alive and off respiratory support (median [25th-75th percentiles], days): placebo: 1 (0-11), 200 IU: 0 (0-8), and 800 IU: 0.5 (0-22); P = .63, or other respiratory outcomes among groups.
Conclusions:
At birth, most extremely preterm infants have biochemical vitamin D deficiency. This biochemical deficiency is reduced on day 28 by supplementation with 200 IU/d and prevented by 800 IU/d. Larger trials are required to determine if resolution of biochemical vitamin D deficiency improves clinical outcomes.
Trial Registration:
ClinicalTrials.gov: NCT01600430.
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