Contact information
Type
Scientific
Primary contact
Prof Haakon E. Meyer
ORCID ID
Contact details
Institute of General Practice and Community Medicine
University of Oslo
P.O. Box 1130
Blindern
Oslo
0318
Norway
+47 480 82 702
h.e.meyer@medisin.uio.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Vitamin D-drops to infants with immigrant background
Study hypothesis
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
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.
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Vitamin D supplementation
Primary outcome measures
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
Secondary outcome measures
Is there any difference between the groups at a second follow-up at eight months of age
Overall trial start date
29/03/2004
Overall trial end date
13/02/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
48 participants (given randomization at the Health Center level)
Participant exclusion criteria
Not applicable
Recruitment start date
29/03/2004
Recruitment end date
13/02/2006
Locations
Countries of recruitment
Norway
Trial participating centre
Institute of General Practice and Community Medicine
Oslo
0318
Norway
Sponsor information
Organisation
The Directorate for Health and Social Affairs (Norway)
Sponsor details
Department of Nutrition
P.O. Box 7000
St. Olavs plass
Oslo
0130
Norway
+ 47 810 20 050
postmottak@shdir.no
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Directorate for Health and Social Affairs, Oslo (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21143588
Publication citations
-
Results
Madar AA, Klepp KI, Meyer HE, The effect of tailor-made information on vitamin D status of immigrant mothers in Norway: a cluster randomized controlled trial., Matern Child Nutr, 2011, 7, 1, 92-99, doi: 10.1111/j.1740-8709.2009.00238.x.