Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000919213
Ethics application status
Approved
Date submitted
22/10/2009
Date registered
26/10/2009
Date last updated
26/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimizing vitamin D supplementation and sun exposure for breastfed infants in Berlin, Germany
Scientific title
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
Secondary ID [1] 1121 0
none
Universal Trial Number (UTN)
U1111-1112-2443
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 252050 0
Condition category
Condition code
Metabolic and Endocrine 252242 252242 0 0
Metabolic disorders
Diet and Nutrition 252247 252247 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplementation with either 250 or 500 units of vitamin D3 per day for 6 weeks using oral tablets
Intervention code [1] 241448 0
Treatment: Drugs
Intervention code [2] 241451 0
Prevention
Comparator / control treatment
The two groups are controls for each other. The need of vitamin D supplementation for infants during their first 1.5 years of life in Germany has been established. Having a group without any supplementation was considered as being unethical.
Control group
Dose comparison

Outcomes
Primary outcome [1] 253116 0
25 hydroxy vitamin D levels in plasma
Timepoint [1] 253116 0
1: day 4 after delivery
Primary outcome [2] 253117 0
25 hydroxy vitamin D levels in plasma
Timepoint [2] 253117 0
2: 6 weeks after delivery
Secondary outcome [1] 257988 0
Sun exposure and exposure to ultraviolet B radiation (UVB) specifically. Exposition was measured with continuous dosimetry.
Dosimeters (BioSpor, Germany) consisted of a biological UV-sensitive film, a special filter-optic system and the protective dosimeter casing. The highly sensitive DNA molecules of immobilised spores produce a responsivity profile, which corresponds to that of human skin. The degree of immobilised spores correlates to the exposures of the dosimeter to an adjustable wavelength of solar radiation. The amount of exposures was measured in minimal erythematous doses (MED). One MED equals the amount of radiation that causes first degree erythema or 250 Joule/m2. A clip was provided to attach the dosimeter to clothes. The optimal position for this badge on the infant's clothing was examined during a test phase on puppets. Parents received precise instructions on how to attach the dosimeter on their infant's clothing on their chest.
To complete the analysis, questionnaires were handed out covering surrounding factors influencing sun exposure like ways of sun protection, clothing or type of baby carrier on a daily basis. This information was transformed into a validated score system (sunshine exposure score, Specker, 1985). Higher scores were equivalent to stronger sun exposure.
Detailed meteorological data were obtained from the Institute of Meteorology at the Freie University, Berlin, Germany, for every day of the study period.
Timepoint [1] 257988 0
Continuous measurement from day 4 until 6 weeks after birth (timepoint 1 until timepoint 2)

Eligibility
Key inclusion criteria
Healthy breastfed newborns, term-delivery, appropriate for gestational age (AGA), skin type II or III
Minimum age
No limit
Maximum age
4 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Vitamin D supplementation during pregnancy, drug abuse, premature delivery, highly pigmented skin (>type III), formula feeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Personal interview of parents, informed written consent.
Randomisation to either 250 or 500 units of vitamin D3 per day using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Choosing odd and even numbers from a sealed opaque envelope (Altman et al, BMJ 1999).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2292 0
Germany
State/province [1] 2292 0
Berlin

Funding & Sponsors
Funding source category [1] 243920 0
Other Collaborative groups
Name [1] 243920 0
Northern German Society of Paediatric and Adolescent Medicine
Country [1] 243920 0
Germany
Primary sponsor type
Charities/Societies/Foundations
Name
German Centre for Growth, Development and Preventative Medicine for Children and Adolescents
Address
Klinik fuer Kinder und Jugendmedizin "Lindenhof"
Gotlindestr 2-20
10365 Berlin
Country
Germany
Secondary sponsor category [1] 251278 0
University
Name [1] 251278 0
University of Western Australia
Address [1] 251278 0
School of Paediatrics and Child Health
Princess Margaret Hospital
Roberts Road
Subiaco, WA 6008
Country [1] 251278 0
Australia
Other collaborator category [1] 914 0
Hospital
Name [1] 914 0
Princess Margaret Hospital for Children
Address [1] 914 0
Department of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country [1] 914 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244033 0
Ethics Committee
Ethics committee address [1] 244033 0
Ethics committee country [1] 244033 0
Germany
Date submitted for ethics approval [1] 244033 0
15/05/1999
Approval date [1] 244033 0
15/10/1999
Ethics approval number [1] 244033 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30412 0
Address 30412 0
Country 30412 0
Phone 30412 0
Fax 30412 0
Email 30412 0
Contact person for public queries
Name 13659 0
Dr Aris Siafarikas
Address 13659 0
Princess Margaret Hospital for Children
Department of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country 13659 0
Australia
Phone 13659 0
+61893408090
Fax 13659 0
+61893408605
Email 13659 0
[email protected]
Contact person for scientific queries
Name 4587 0
Dr Aris Siafarikas
Address 4587 0
Princess Margaret Hospital for Children
Department of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country 4587 0
Australia
Phone 4587 0
+61893408090
Fax 4587 0
+61893408605
Email 4587 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIRandomised controlled trial analysing supplementation with 250 versus 500 units of vitamin D3, sun exposure and surrounding factors in breastfed infants2010https://doi.org/10.1136/adc.2009.178301
N.B. These documents automatically identified may not have been verified by the study sponsor.