CompletedPhase 2Phase 3ACTRN12613001234707

A randomised controlled trial comparing daily (400 international units) and single bolus dosing (50,000 international units) of vitamin D in healthy breastfed infants of vitamin D deficient mothers.

A randomised controlled trial evaluating the efficacy and safety of single bolus (50,000 international units) versus daily (400 international units) dosing of vitamin D in healthy breastfed infants of vitamin D deficient mothers.


Sponsor

Sunshine Hospital

Enrollment

70 participants

Start Date

Aug 12, 2013

Study Type

Interventional

Conditions

Summary

To assess the proportion of breastfed infants who are vitamin D sufficient (25 OH vit D > 50nmol/L) in the intervention group (bolus vitamin D dosing) versus the standard daily vitamin D dosing. This will be achieved by measurement of 25 OH vit D levels ; a marker of vitamin D status. This is an open label, single site - hospital based centre Primary: Proportion of subjects at 4 months of age with 25 OH vit D levels > 50nmol/L. Secondary: Total calcium as marker of safety, compliance, clinical markers of vitamin D deficiency Recruitment period: May – Feb 2014. Four month follow up period 1) 400 IU vitamin D daily 2) 50,000 IU at birth only (bolus) Sample size of 70 with 28 in each group + drop out rate. Term breastfed infants born to pregnant women who are found to be vitamin D deficient (25 OH vit D < 50nmol/L) at 35-37 weeks gestation


Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 5 Monthss

Inclusion Criteria3

  • term, singleton babies
  • mothers with vitamin D levels < 50 at > 35 week
  • intention to breastfeed

Exclusion Criteria5

  • intra-uterine growth restriction
  • pre-existing maternal diabetes, thyroid disorders
  • Neonates requiring significant resuscitation, CPR and intubation
  • maternal drug dependence
  • twin pregnancies

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Interventions

arm 1: 400IU vitamin D orally - Pentavite (Bayer Health) given daily for 4 months from birth arm 2: 50,000 vitamin D orally - Given as pharmacy formulated Cholecalciferol as a single dose at birth on

arm 1: 400IU vitamin D orally - Pentavite (Bayer Health) given daily for 4 months from birth arm 2: 50,000 vitamin D orally - Given as pharmacy formulated Cholecalciferol as a single dose at birth only. Patients will be followed up at 6-8 days of age and 3-4 months of age for biochemical markers of vitamin D deficiency (vitamin D and calcium levels) and reviewed for compliance, growth, side effects and signs of vitamin d deficiency


Locations(1)

VIC, Australia

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ACTRN12613001234707