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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001234707

Enrollment

Registered

2013-11-12

Start date

2013-08-12

Completion date

2013-11-29

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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 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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

0 to 5 Months

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Outcome results