Vitamin D StatusVIDINCT01723852
Vitamin D Intervention in Infants
A study testing Vitamin D at 30 ug/day and Vitamin D at 10 ug/day in people with Vitamin D Status, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and… Read more about this study
- Who is it for?
- Ages Up to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status
- What is being tested?
- Vitamin D at 30 ug/day and Vitamin D at 10 ug/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2013to 20 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born at term (37-42 wks, weight appropriate for gestational age) are included in the study
Who cannot join
- Non Caucasian mother
- Any continuous regular medication of mother
- Treatment at neonatal intensive care unit
- Antibiotic treatment of the infant
- Congenital malformations of the newborn
- Treatment with ventilation support (continuous nasal positive airway pressure) for over 24 hours
Show all 10Show fewer
- Glucose infusion of the newborn
- Neurological symptoms of the newborn
- Phototherapy for jaundice of the newborn
- Need for nasogastric feeding of the newborn
Trial locations and contacts
1 site in 1 country.
About this study
The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.
- Conditions
- Vitamin D Status
- Being tested
- Vitamin D at 30 ug/day, Vitamin D at 10 ug/day
- Keywords
- Vitamin D, Infectious diseases, cognitive development, Bone mineral density, Immunoregulation, Allergy, Growth
- Medical subject headings
- Communicable Diseases, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D at 30 ug/dayDietary supplement
Vitamin D at 10 ug/dayDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplement | Active comparator | Vitamin D supplement according to national guidelines (10 ug/day) from 2 weeks to 2 years of age Receives: Dietary Supplement: Vitamin D at 10 ug/day |
| Vitamin D supplement at 30 ug/day | Active comparator | Vitamin D supplement at 30 ug/day from 2 weeks to 2 years of age Receives: Dietary Supplement: Vitamin D at 30 ug/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Measurement of growth at 2 years of age
Measured: 2 years of age
Neurologic and cognitive development
By means of questionnaires and, on a randomly selected group of study subjects, cognitive function testing to assess neurologic and cognitive development
Measured: At 2 years of age
Frequency of allergic symptoms and infection
Assessment of the frequency of allergic symptoms and infections by means of questionnaires, hospital discharge records and prescription data.
Measured: At 2 years of age
Development of immunoregulation
Assessment of the tolerogenic properties of T-cells and dendritic cell function from blood sample in a subgroup of 100 study subjects.
Measured: At 2 years of age
Bone mineral density
Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography
Measured: 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startJan 2013
- Primary completion15 Jul 2016
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Vitamin D StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Finnish Governmental Special Subsidy for Health Sciences Research, Päivikki and Sakari Sohlberg Foundation, Finland, The Finnish Medical Association
- Responsible party
- Principal investigator, Sture Andersson, Helsinki University Central Hospital
- Investigators
- Sture Andersson, MD, PhD, Principal investigator, Helsinki University Central Hospital, Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723852
- Sponsor's protocol ID
- VIDI-2012-01
- Acronym
- VIDI
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2012
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holmlund-Suila E, Viljakainen H, Hytinantti T, Lamberg-Allardt C, Andersson S, Makitie O. High-dose vitamin d intervention in infants--effects on vitamin d status, calcium homeostasis, and bone strength. J Clin Endocrinol Metab. 2012 Nov;97(11):4139-47. doi: 10.1210/jc.2012-1575. Epub 2012 Aug 29.
PubMed 22933541Helve O, Viljakainen H, Holmlund-Suila E, Rosendahl J, Hauta-Alus H, Enlund-Cerullo M, Valkama S, Heinonen K, Raikkonen K, Hytinantti T, Makitie O, Andersson S. Towards evidence-based vitamin D supplementation in infants: vitamin D intervention in infants (VIDI) - study design and methods of a randomised controlled double-blinded intervention study. BMC Pediatr. 2017 Mar 29;17(1):91. doi: 10.1186/s12887-017-0845-5.
PubMed 28356142Rosendahl J, Holmlund-Suila E, Helve O, Viljakainen H, Hauta-Alus H, Valkama S, Enlund-Cerullo M, Hytinantti T, Tervahartiala T, Sorsa T, Makitie O, Andersson S. 25-hydroxyvitamin D correlates with inflammatory markers in cord blood of healthy newborns. Pediatr Res. 2017 May;81(5):731-735. doi: 10.1038/pr.2017.9. Epub 2017 Jan 13.
PubMed 28085793Hauta-Alus HH, Holmlund-Suila EM, Rita HJ, Enlund-Cerullo M, Rosendahl J, Valkama SM, Helve OM, Hytinantti TK, Surcel HM, Makitie OM, Andersson S, Viljakainen HT. Season, dietary factors, and physical activity modify 25-hydroxyvitamin D concentration during pregnancy. Eur J Nutr. 2018 Jun;57(4):1369-1379. doi: 10.1007/s00394-017-1417-z. Epub 2017 Mar 2.
PubMed 28255653Valkama S, Holmlund-Suila E, Enlund-Cerullo M, Rosendahl J, Hauta-Alus H, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O. No Severe Hypercalcemia with Daily Vitamin D3 Supplementation of up to 30 microg during the First Year of Life. Horm Res Paediatr. 2017;88(2):147-154. doi: 10.1159/000477298. Epub 2017 Jun 23.
PubMed 28647736Holmlund-Suila E, Enlund-Cerullo M, Valkama S, Hauta-Alus H, Rosendahl J, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O. Sex and Iron Modify Fibroblast Growth Factor 23 Concentration in 1-Year-Old Children. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4526-4533. doi: 10.1210/jc.2017-01211.
PubMed 29029193Sandboge S, Seppala V, Lintula S, Holmlund-Suila E, Hauta-Alus H, Kajantie E, Makitie O, Andersson S, Raikkonen K, Heinonen K. Vitamin D supplementation in the first 2 years and autism spectrum traits at 6-8 years - a randomized clinical trial. J Child Psychol Psychiatry. 2026 Jul;67(7):1004-1014. doi: 10.1111/jcpp.70110. Epub 2026 Jan 5.
PubMed 41486975Seppala V, Sandboge S, Holmlund-Suila E, Hauta-Alus H, Lintula S, Kajantie E, Makitie O, Andersson S, Raikkonen K, Heinonen K. Early life vitamin D and neurocognitive abilities at age 6-8 years: a randomized clinical trial and observational analysis. Eur Child Adolesc Psychiatry. 2026 Feb;35(2):587-597. doi: 10.1007/s00787-025-02891-7. Epub 2025 Oct 10.
PubMed 41071326Enlund-Cerullo M, Holmlund-Suila E, Valkama S, Hauta-Alus H, Rosendahl J, Andersson S, Pekkinen M, Makitie O. Variation in the fibroblast growth factor 23 (FGF23) gene associates with serum FGF23 and bone strength in infants. Front Genet. 2023 May 22;14:1192368. doi: 10.3389/fgene.2023.1192368. eCollection 2023.
PubMed 37284066Sandboge S, Raikkonen K, Lahti-Pulkkinen M, Hauta-Alus H, Holmlund-Suila E, Girchenko P, Kajantie E, Makitie O, Andersson S, Heinonen K. Effect of Vitamin D3 Supplementation in the First 2 Years of Life on Psychiatric Symptoms at Ages 6 to 8 Years: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314319. doi: 10.1001/jamanetworkopen.2023.14319.
PubMed 37204794Pontan F, Hauta-Alus H, Valkama S, Rosendahl J, Enlund-Cerullo M, Andersson S, Makitie O, Holmlund-Suila E. Alkaline Phosphatase and Hyperphosphatasemia in Vitamin D Trial in Healthy Infants and Toddlers. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1082-e1091. doi: 10.1210/clinem/dgad208.
PubMed 37061810Holmlund-Suila EM, Hauta-Alus HH, Enlund-Cerullo M, Rosendahl J, Valkama SM, Andersson S, Makitie O. Iron status in early childhood is modified by diet, sex and growth: Secondary analysis of a randomized controlled vitamin D trial. Clin Nutr. 2022 Feb;41(2):279-287. doi: 10.1016/j.clnu.2021.12.013. Epub 2021 Dec 13.
PubMed 34999321Tuovinen S, Raikkonen K, Holmlund-Suila E, Hauta-Alus H, Helve O, Rosendahl J, Enlund-Cerullo M, Kajantie E, Valkama S, Viljakainen H, Makitie O, Andersson S, Heinonen K. Effect of High-Dose vs Standard-Dose Vitamin D Supplementation on Neurodevelopment of Healthy Term Infants: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2124493. doi: 10.1001/jamanetworkopen.2021.24493.
PubMed 34495336Koljonen L, Enlund-Cerullo M, Hauta-Alus H, Holmlund-Suila E, Valkama S, Rosendahl J, Andersson S, Pekkinen M, Makitie O. Phosphate Concentrations and Modifying Factors in Healthy Children From 12 to 24 Months of Age. J Clin Endocrinol Metab. 2021 Sep 27;106(10):2865-2875. doi: 10.1210/clinem/dgab495.
PubMed 34214153Hauta-Alus HH, Holmlund-Suila EM, Kajantie E, Rosendahl J, Valkama SM, Enlund-Cerullo M, Andersson S, Makitie O. The Effects of Vitamin D Supplementation During Infancy on Growth During the First 2 Years of Life. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1140-e1155. doi: 10.1210/clinem/dgaa943.
PubMed 33347567
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Intervention in Infants
- ClinicalTrials.gov ID
- NCT01723852
- Acronym / sponsor ID
- VIDI / VIDI-2012-01
- Conditions
- Vitamin D Status
- Keywords
- Vitamin D, Infectious diseases, cognitive development, Bone mineral density, Immunoregulation, Allergy, Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- The Finnish Governmental Special Subsidy for Health Sciences Research, Päivikki and Sakari Sohlberg Foundation, Finland, The Finnish Medical Association
- Study start
- Jan 2013 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 8 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplement | Active comparator | Dietary Supplement: Vitamin D at 10 ug/dayVitamin D supplement according to national guidelines (10 ug/day) from 2 weeks to 2 years of age |
| Vitamin D supplement at 30 ug/day | Active comparator | Dietary Supplement: Vitamin D at 30 ug/dayVitamin D supplement at 30 ug/day from 2 weeks to 2 years of age |
Who may qualify
- Ages
- Up to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born at term (37-42 wks, weight appropriate for gestational age) are included in the study
Key exclusion criteria (10 listed)
- Non Caucasian mother
- Any continuous regular medication of mother
- Treatment at neonatal intensive care unit
- Antibiotic treatment of the infant
- Congenital malformations of the newborn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D at 30 ug/day | Dietary supplement | Vitamin D supplement at 30 ug/day |
| Vitamin D at 10 ug/day | Dietary supplement | Vitamin D supplement |
Primary outcome
Growth
Time frame: 2 years of age
Measurement of growth at 2 years of age
Neurologic and cognitive development
Time frame: At 2 years of age
By means of questionnaires and, on a randomly selected group of study subjects, cognitive function testing to assess neurologic and cognitive development
Frequency of allergic symptoms and infection
Time frame: At 2 years of age
Assessment of the frequency of allergic symptoms and infections by means of questionnaires, hospital discharge records and prescription data.
Development of immunoregulation
Time frame: At 2 years of age
Assessment of the tolerogenic properties of T-cells and dendritic cell function from blood sample in a subgroup of 100 study subjects.
Bone mineral density
Time frame: 2 years of age
Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Background: PubMed 22933541Holmlund-Suila E, Viljakainen H, Hytinantti T, Lamberg-Allardt C, Andersson S, Makitie O. High-dose vitamin d intervention in infants--effects on vitamin d status, calcium homeostasis, and bone strength. J Clin Endocrinol Metab. 2012 Nov;97(11):4139-47. doi: 10.1210/jc.2012-1575. Epub 2012 Aug 29.
- Background: PubMed 28356142Helve O, Viljakainen H, Holmlund-Suila E, Rosendahl J, Hauta-Alus H, Enlund-Cerullo M, Valkama S, Heinonen K, Raikkonen K, Hytinantti T, Makitie O, Andersson S. Towards evidence-based vitamin D supplementation in infants: vitamin D intervention in infants (VIDI) - study design and methods of a randomised controlled double-blinded intervention study. BMC Pediatr. 2017 Mar 29;17(1):91. doi: 10.1186/s12887-017-0845-5.
- Results publication: PubMed 28085793Rosendahl J, Holmlund-Suila E, Helve O, Viljakainen H, Hauta-Alus H, Valkama S, Enlund-Cerullo M, Hytinantti T, Tervahartiala T, Sorsa T, Makitie O, Andersson S. 25-hydroxyvitamin D correlates with inflammatory markers in cord blood of healthy newborns. Pediatr Res. 2017 May;81(5):731-735. doi: 10.1038/pr.2017.9. Epub 2017 Jan 13.
- Results publication: PubMed 28255653Hauta-Alus HH, Holmlund-Suila EM, Rita HJ, Enlund-Cerullo M, Rosendahl J, Valkama SM, Helve OM, Hytinantti TK, Surcel HM, Makitie OM, Andersson S, Viljakainen HT. Season, dietary factors, and physical activity modify 25-hydroxyvitamin D concentration during pregnancy. Eur J Nutr. 2018 Jun;57(4):1369-1379. doi: 10.1007/s00394-017-1417-z. Epub 2017 Mar 2.
- Results publication: PubMed 28647736Valkama S, Holmlund-Suila E, Enlund-Cerullo M, Rosendahl J, Hauta-Alus H, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O. No Severe Hypercalcemia with Daily Vitamin D3 Supplementation of up to 30 microg during the First Year of Life. Horm Res Paediatr. 2017;88(2):147-154. doi: 10.1159/000477298. Epub 2017 Jun 23.
- Results publication: PubMed 29029193Holmlund-Suila E, Enlund-Cerullo M, Valkama S, Hauta-Alus H, Rosendahl J, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O. Sex and Iron Modify Fibroblast Growth Factor 23 Concentration in 1-Year-Old Children. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4526-4533. doi: 10.1210/jc.2017-01211.
- Derived from this study: PubMed 41486975Sandboge S, Seppala V, Lintula S, Holmlund-Suila E, Hauta-Alus H, Kajantie E, Makitie O, Andersson S, Raikkonen K, Heinonen K. Vitamin D supplementation in the first 2 years and autism spectrum traits at 6-8 years - a randomized clinical trial. J Child Psychol Psychiatry. 2026 Jul;67(7):1004-1014. doi: 10.1111/jcpp.70110. Epub 2026 Jan 5.
- Derived from this study: PubMed 41071326Seppala V, Sandboge S, Holmlund-Suila E, Hauta-Alus H, Lintula S, Kajantie E, Makitie O, Andersson S, Raikkonen K, Heinonen K. Early life vitamin D and neurocognitive abilities at age 6-8 years: a randomized clinical trial and observational analysis. Eur Child Adolesc Psychiatry. 2026 Feb;35(2):587-597. doi: 10.1007/s00787-025-02891-7. Epub 2025 Oct 10.
- Derived from this study: PubMed 37284066Enlund-Cerullo M, Holmlund-Suila E, Valkama S, Hauta-Alus H, Rosendahl J, Andersson S, Pekkinen M, Makitie O. Variation in the fibroblast growth factor 23 (FGF23) gene associates with serum FGF23 and bone strength in infants. Front Genet. 2023 May 22;14:1192368. doi: 10.3389/fgene.2023.1192368. eCollection 2023.
- Derived from this study: PubMed 37204794Sandboge S, Raikkonen K, Lahti-Pulkkinen M, Hauta-Alus H, Holmlund-Suila E, Girchenko P, Kajantie E, Makitie O, Andersson S, Heinonen K. Effect of Vitamin D3 Supplementation in the First 2 Years of Life on Psychiatric Symptoms at Ages 6 to 8 Years: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314319. doi: 10.1001/jamanetworkopen.2023.14319.
- Derived from this study: PubMed 37061810Pontan F, Hauta-Alus H, Valkama S, Rosendahl J, Enlund-Cerullo M, Andersson S, Makitie O, Holmlund-Suila E. Alkaline Phosphatase and Hyperphosphatasemia in Vitamin D Trial in Healthy Infants and Toddlers. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1082-e1091. doi: 10.1210/clinem/dgad208.
- Derived from this study: PubMed 34999321Holmlund-Suila EM, Hauta-Alus HH, Enlund-Cerullo M, Rosendahl J, Valkama SM, Andersson S, Makitie O. Iron status in early childhood is modified by diet, sex and growth: Secondary analysis of a randomized controlled vitamin D trial. Clin Nutr. 2022 Feb;41(2):279-287. doi: 10.1016/j.clnu.2021.12.013. Epub 2021 Dec 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sture Andersson, MD, PhD principal investigator
Helsinki University Central Hospital, Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D at 30 ug/day and Vitamin D at 10 ug/day in people with Vitamin D Status, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth (time frame: 2 years of age). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01723852, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.