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
Scientific
Institute of General Practice and Community Medicine
University of Oslo
P.O. Box 1130
Blindern
Oslo
0318
Norway
| Phone | +47 480 82 702 |
|---|---|
| h.e.meyer@medisin.uio.no |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 29/03/2004 |
| Completion date | 13/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | 48 participants (given randomization at the Health Center level) |
| 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
0318
Norway
Sponsor information
The Directorate for Health and Social Affairs (Norway)
Government
Government
Department of Nutrition
P.O. Box 7000
St. Olavs plass
Oslo
0130
Norway
| Phone | + 47 810 20 050 |
|---|---|
| postmottak@shdir.no | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
