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
Protocol serial number	N/A
Sponsor	The Directorate for Health and Social Affairs (Norway)
Funder	The Directorate for Health and Social Affairs, Oslo (Norway)

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

Primary study design	Interventional
Study design	Open 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.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Vitamin D-drops to infants with immigrant background
Study objectives	The 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) studied	Vitamin D-deficiency
Intervention	Intervention 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 type	Supplement
Primary outcome measure(s)	1. 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
Key secondary outcome measure(s)	Is there any difference between the groups at a second follow-up at eight months of age
Completion date	13/02/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Target sample size at registration	48
Key inclusion criteria	1. Infants with Pakistani, Turkish or Somali background 2. Coming to routine consultation six weeks after birth in eight Health Centers in Oslo
Key exclusion criteria	Not applicable
Date of first enrolment	29/03/2004
Date of final enrolment	13/02/2006

Locations

Countries of recruitment

Norway

Study participating centre

Institute of General Practice and Community Medicine

Oslo
0318
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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