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| Name | Class |
|---|---|
| The Finnish Governmental Special Subsidy for Health Sciences Research | UNKNOWN |
| Päivikki and Sakari Sohlberg Foundation, Finland | OTHER |
| The Finnish Medical Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D supplement | Active Comparator | Vitamin 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 | Vitamin D supplement at 30 ug/day from 2 weeks to 2 years of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D at 30 ug/day | Dietary Supplement |
| ||
| Vitamin D at 10 ug/day |
| Measure | Description | Time Frame |
|---|---|---|
| Growth | Measurement of growth at 2 years of age | 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 | 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. | 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. | At 2 years of age |
| Bone mineral density | Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography | 2 years of age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sture Andersson, MD, PhD | Helsinki University Central Hospital, Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kätilöopisto Maternity Hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22933541 | Background | 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. | |
| 28356142 | Background |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dietary Supplement |
|
| Helve 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. |
| 28085793 | Result | Rosendahl 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. |
| 28255653 | Result | Hauta-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. |
| 28647736 | Result | Valkama 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. |
| 29029193 | Result | Holmlund-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. |
| 41071326 | Derived | Seppala 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. |
| 37284066 | Derived | Enlund-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. |
| 37204794 | Derived | Sandboge 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. |
| 37061810 | Derived | Pontan 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. |
| 34999321 | Derived | Holmlund-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. |
| 34495336 | Derived | Tuovinen 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. |
| 34214153 | Derived | Koljonen 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. |
| 33347567 | Derived | Hauta-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. |
| 33305842 | Derived | Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2. |
| 33007527 | Derived | Valkama S, Holmlund-Suila E, Ireland A, Hauta-Alus H, Enlund-Cerullo M, Rosendahl J, Andersson S, Makitie O. Peripheral quantitative computed tomography (pQCT) in 12- and 24-month-old children - Practical aspects and descriptive data. Bone. 2020 Dec;141:115670. doi: 10.1016/j.bone.2020.115670. Epub 2020 Sep 30. |
| 32919110 | Derived | Enlund-Cerullo M, Hauta-Alus H, Valkama S, Rosendahl J, Andersson S, Makitie O, Holmlund-Suila E. Fibroblast growth factor 23 concentrations and modifying factors in children from age 12 to 24 months. Bone. 2020 Dec;141:115629. doi: 10.1016/j.bone.2020.115629. Epub 2020 Sep 10. |
| 31365099 | Derived | Enlund-Cerullo M, Koljonen L, Holmlund-Suila E, Hauta-Alus H, Rosendahl J, Valkama S, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O, Pekkinen M. Genetic Variation of the Vitamin D Binding Protein Affects Vitamin D Status and Response to Supplementation in Infants. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5483-5498. doi: 10.1210/jc.2019-00630. |
| 30247704 | Derived | Hauta-Alus HH, Kajantie E, Holmlund-Suila EM, Rosendahl J, Valkama SM, Enlund-Cerullo M, Helve OM, Hytinantti TK, Viljakainen H, Andersson S, Makitie O. High Pregnancy, Cord Blood, and Infant Vitamin D Concentrations May Predict Slower Infant Growth. J Clin Endocrinol Metab. 2019 Feb 1;104(2):397-407. doi: 10.1210/jc.2018-00602. |
| 29813149 | Derived | Rosendahl J, Valkama S, Holmlund-Suila E, Enlund-Cerullo M, Hauta-Alus H, Helve O, Hytinantti T, Levalahti E, Kajantie E, Viljakainen H, Makitie O, Andersson S. Effect of Higher vs Standard Dosage of Vitamin D3 Supplementation on Bone Strength and Infection in Healthy Infants: A Randomized Clinical Trial. JAMA Pediatr. 2018 Jul 1;172(7):646-654. doi: 10.1001/jamapediatrics.2018.0602. |
| 29246128 | Derived | Hauta-Alus HH, Viljakainen HT, Holmlund-Suila EM, Enlund-Cerullo M, Rosendahl J, Valkama SM, Helve OM, Hytinantti TK, Makitie OM, Andersson S. Maternal vitamin D status, gestational diabetes and infant birth size. BMC Pregnancy Childbirth. 2017 Dec 15;17(1):420. doi: 10.1186/s12884-017-1600-5. |
| D007154 | Immune System Diseases |