Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/11/2006
Date assigned
14/12/2006
Last edited
31/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes