The effect of free vitamin D-drops and tailor-made information on serum 25-hydroxyvitamin D among infants of immigrant origin in Oslo, Norway: a randomised controlled trial

ISRCTN ISRCTN78298308
DOI https://doi.org/10.1186/ISRCTN78298308
Secondary identifying numbers N/A
Submission date
08/11/2006
Registration date
14/12/2006
Last edited
31/03/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Haakon E. Meyer
Scientific

Institute of General Practice and Community Medicine
University of Oslo
P.O. Box 1130
Blindern
Oslo
0318
Norway

Phone +47 480 82 702
Email h.e.meyer@medisin.uio.no

Study information

Study designOpen randomised controlled trial. Carried out at the Health Centre level. Health Centres were paired based on size. Randomisation was then carried out within each pair.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymVitamin D-drops to infants with immigrant background
Study objectivesThe main objective of the trial is to study whether free supply of vitamin D drops to six weeks old infants of immigrants from Pakistan, Turkey and Somalia together with tailor-made information handouts improves vitamin D status at the age of three months in the intervention group compared to a control group.

In addition, to study whether the information given also improves vitamin D status in the mothers in the intervention group compared to the control group.
Ethics approval(s)Approved by the ombudsman for privacy in research (ref: 200301024) on the 5th November 2003 and the Regional Committee for Medical Research Ethics (REK Sør) (ref: S-03196) on the 6th November 2003.
Health condition(s) or problem(s) studiedVitamin D-deficiency
InterventionIntervention group:
Provision of free vitamin D drops and instruction on how to administer it to their infants, including a tailored-made information brochure about vitamin D and its sources which have been translated to Urdu, Turkish and Somali.

Control group:
Usual care consisting of routine information about vitamin D and recommendation of use of vitamin D supplements, preferably cod liver oil.
Intervention typeSupplement
Primary outcome measure1. Change in 25-hydroxyvitamin D from baseline (six week of age) to follow-up (three months of age) in the intervention group compared to the control group, adjusted for baseline level of 25-hydroxyvitamin D
2. Change in 25-hydroxyvitamin D from baseline to follow-up in the mothers in the intervention group compared to the mothers in the control group, adjusted for baseline level of 25-hydroxyvitamin D
Secondary outcome measuresIs there any difference between the groups at a second follow-up at eight months of age
Overall study start date29/03/2004
Completion date13/02/2006

Eligibility

Participant type(s)Patient
Age groupChild
SexNot Specified
Target number of participants48 participants (given randomization at the Health Center level)
Key inclusion criteria1. Infants with Pakistani, Turkish or Somali background
2. Coming to routine consultation six weeks after birth in eight Health Centers in Oslo
Key exclusion criteriaNot applicable
Date of first enrolment29/03/2004
Date of final enrolment13/02/2006

Locations

Countries of recruitment

  • Norway

Study participating centre

Institute of General Practice and Community Medicine
Oslo
0318
Norway

Sponsor information

The Directorate for Health and Social Affairs (Norway)
Government

Department of Nutrition
P.O. Box 7000
St. Olavs plass
Oslo
0130
Norway

Phone + 47 810 20 050
Email postmottak@shdir.no
ROR logo "ROR" https://ror.org/01d2cn965

Funders

Funder type

Government

The Directorate for Health and Social Affairs, Oslo (Norway)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2011 Yes No