Optimizing vitamin D supplementation and sun exposure for breastfed infants in Berlin, Germany

An assessment of the minimal amount of vitamin D supplementation and sun exposure required to provide a sufficient vitamin D status in breastfed infants during their first 6 weeks of life

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000919213

Enrollment

Registered

2009-10-26

Start date

2000-01-01

Completion date

Unknown

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

Background: The rate of non-compliance with vitamin D supplementation in countries of Northern latitude is as high as 45%. Objective: To specify the minimal amount of vitamin D supplementation and sun exposure required to provide a sufficient vitamin D status. Design: 40 infants (World Health Organisation (WHO) skin types I,II) were recruited in Berlin, Germany (Latitude: 52.5 degrees North) during summer (n=20) and winter (n=20) and randomized into equal groups on either 250 units or 500 units of vitamin D3 per day. Outcome measures were: parameters of vitamin D (25(OH)D) and bone metabolism at delivery and 6 weeks later, sun exposure time, UVB dosimetry and surrounding factors including mother’s diet.

Interventions

Supplementation with either 250 or 500 units of vitamin D3 per day for 6 weeks using oral tablets

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 4 Days

Healthy volunteers

Yes

Inclusion criteria

Healthy breastfed newborns, term-delivery, appropriate for gestational age (AGA), skin type II or III

Exclusion criteria

Vitamin D supplementation during pregnancy, drug abuse, premature delivery, highly pigmented skin (>type III), formula feeding

Outcome results