Vitamin D Intervention in Infants

NCT01723852 | Completed DMC

• 1 other identifier: VIDI-2012-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 development of immunoregulation assessed at 2 years of age.

Conditions

Vitamin D Status

Keywords

Vitamin D; Infectious diseases; cognitive development; Bone mineral density; Immunoregulation; Allergy; Growth

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Vitamin D supplement

ACTIVE COMPARATOR

Vitamin D supplement according to national guidelines (10 ug/day) from 2 weeks to 2 years of age

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

Dietary Supplement: Vitamin D at 30 ug/day

Interventions

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

Eligibility Criteria

• Age: Up to 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants born at term (37-42 wks, weight appropriate for gestational age) are included in the study

You may not qualify if:

• 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
• Glucose infusion of the newborn
• Neurological symptoms of the newborn
• Phototherapy for jaundice of the newborn
• Need for nasogastric feeding of the newborn

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• The Finnish Governmental Special Subsidy for Health Sciences Research: collaborator
• Päivikki and Sakari Sohlberg Foundation, Finland: collaborator
• The Finnish Medical Association: collaborator

Study Sites (1)

Kätilöopisto Maternity Hospital

Helsinki, 00029, Finland

Location

Related Publications (21)

• 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.

  PMID: 22933541 BACKGROUND

• 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.

  PMID: 28356142 BACKGROUND

• 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.

  PMID: 28085793 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.

  PMID: 28255653 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.

  PMID: 28647736 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.

  PMID: 29029193 RESULT

• 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. 2025 Oct 10. doi: 10.1007/s00787-025-02891-7. Online ahead of print.

  PMID: 41071326 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.

  PMID: 37284066 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.

  PMID: 37204794 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.

  PMID: 37061810 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.

  PMID: 34999321 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.

  PMID: 34495336 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.

  PMID: 34214153 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.

  PMID: 33347567 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.

  PMID: 33305842 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.

  PMID: 33007527 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.

  PMID: 32919110 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.

  PMID: 31365099 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.

  PMID: 30247704 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.

  PMID: 29813149 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.

  PMID: 29246128 DERIVED

MeSH Terms

Conditions

Communicable Diseases; Hypersensitivity

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Sture Andersson, MD, PhD

  Helsinki University Central Hospital, Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neonatology

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 8, 2012
• Study Start: January 1, 2013
• Primary Completion: July 15, 2016
• Study Completion: November 20, 2017
• Last Updated: November 21, 2017

Record last verified: 2017-11

Locations

FI (1)