BACKGROUND: Many extremely preterm infants have low vitamin D concentrations at birth, but early childhood outcomes after vitamin D supplementation have not been reported. OBJECTIVE: To determine a dose-response relationship between increasing doses of enteral vitamin D in the first 28 days after birth and cognitive scores at 2 years of age. METHODS: In this phase II double-blind dose-response randomized trial, infants with gestational ages between 23 and 27 weeks were randomly assigned to receive placebo or a vitamin D dose of 200 or 800 IU/day from day 1 of enteral feeding to postnatal day 28. The primary outcome of this follow-up study was Bayley III cognitive score at 22-26 months of age. RESULTS:Seventy of 80 survivors had a follow-up evaluation at 2 years of age (88%). There were no significant differences in cognitive scores between supplementation groups (p = 0.47). Cognitive scores did not differ between the higher vitamin D dose group and the placebo group (median difference favoring the 800 IU group: +5 points; 95% CI: -5 to 15; p = 0.23). The linear trend between increasing doses of vitamin D and reduction of neurodevelopmental impairment (placebo group: 54%; 200 IU group: 43%; 800 IU group: 30%; p = 0.08) or language impairment (placebo group: 64%; 200 IU group: 57%; 800 IU group: 45%; p = 0.15) was not statistically significant. Respiratory outcomes at 2 years of age (need for supplemental oxygen or asthma medications) did not differ between groups. CONCLUSION: In extremely preterm infants, early vitamin D supplementation did not significantly improve cognitive scores. Though underpowered for clinically meaningful differences in early childhood outcomes, this trial may help determine dosing for further investigation of vitamin D supplementation.
RCT Entities:
BACKGROUND: Many extremely preterm infants have low vitamin D concentrations at birth, but early childhood outcomes after vitamin D supplementation have not been reported. OBJECTIVE: To determine a dose-response relationship between increasing doses of enteral vitamin D in the first 28 days after birth and cognitive scores at 2 years of age. METHODS: In this phase II double-blind dose-response randomized trial, infants with gestational ages between 23 and 27 weeks were randomly assigned to receive placebo or a vitamin D dose of 200 or 800 IU/day from day 1 of enteral feeding to postnatal day 28. The primary outcome of this follow-up study was Bayley III cognitive score at 22-26 months of age. RESULTS: Seventy of 80 survivors had a follow-up evaluation at 2 years of age (88%). There were no significant differences in cognitive scores between supplementation groups (p = 0.47). Cognitive scores did not differ between the higher vitamin D dose group and the placebo group (median difference favoring the 800 IU group: +5 points; 95% CI: -5 to 15; p = 0.23). The linear trend between increasing doses of vitamin D and reduction of neurodevelopmental impairment (placebo group: 54%; 200 IU group: 43%; 800 IU group: 30%; p = 0.08) or language impairment (placebo group: 64%; 200 IU group: 57%; 800 IU group: 45%; p = 0.15) was not statistically significant. Respiratory outcomes at 2 years of age (need for supplemental oxygen or asthma medications) did not differ between groups. CONCLUSION: In extremely preterm infants, early vitamin D supplementation did not significantly improve cognitive scores. Though underpowered for clinically meaningful differences in early childhood outcomes, this trial may help determine dosing for further investigation of vitamin D supplementation.
Authors: Jacqueline F Gould; Amanda J Anderson; Lisa N Yelland; Lisa G Smithers; C Murray Skeaff; Shao J Zhou; Robert A Gibson; Maria Makrides Journal: J Paediatr Child Health Date: 2016-08-27 Impact factor: 1.954
Authors: Roberta A McCarthy; Malachi J McKenna; Oyinkansola Oyefeso; Ogenna Uduma; Barbara F Murray; Jennifer J Brady; Mark T Kilbane; John F Murphy; Anne Twomey; Colm P O' Donnell; Nuala P Murphy; Eleanor J Molloy Journal: Br J Nutr Date: 2012-11-27 Impact factor: 3.718
Authors: C R Gale; S M Robinson; N C Harvey; M K Javaid; B Jiang; C N Martyn; K M Godfrey; C Cooper Journal: Eur J Clin Nutr Date: 2007-02-21 Impact factor: 4.016
Authors: Lisa M Hortensius; Ruurd M van Elburg; Cora H Nijboer; Manon J N L Benders; Caroline G M de Theije Journal: Front Physiol Date: 2019-07-26 Impact factor: 4.566
Authors: Agnes M Mutua; Margaret Nampijja; Alison M Elliott; John M Pettifor; Thomas N Williams; Amina Abubakar; Emily L Webb; Sarah H Atkinson Journal: Nutrients Date: 2020-06-03 Impact factor: 6.706
Authors: Amina Abubakar; Sarah H Atkinson; Agnes M Mutua; Reagan M Mogire; Alison M Elliott; Thomas N Williams; Emily L Webb Journal: Wellcome Open Res Date: 2020-06-11