Vitamin D Intervention in Infants

Vitamin D Status Clinical Trial

— VIDI  

Official title:

Vitamin D Intervention in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723852
• Other study ID #: VIDI-2012-01
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: November 20, 2017
• Start date: January 2013
• Est. completion date: November 20, 2017

Study information

• Verified date: November 2017
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 development of immunoregulation assessed at 2 years of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: November 20, 2017
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Days

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Vitamin D Status

Intervention

Dietary Supplement:
• Vitamin D at 30 ug/day

• Vitamin D at 10 ug/day

Locations

Country	Name	City	State
Finland	Kätilöopisto Maternity Hospital	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Finska Läkaresällskapet, Päivikki and Sakari Sohlberg Foundation, Finland, The Finnish Governmental Special Subsidy for Health Sciences Research

Country where clinical trial is conducted

Finland, 

References & Publications (6)

Hauta-Alus HH, Holmlund-Suila EM, Rita HJ, Enlund-Cerullo M, Rosendahl J, Valkama SM, Helve OM, Hytinantti TK, Surcel HM, Mäkitie OM, Andersson S, Viljakainen HT. Season, dietary factors, and physical activity modify 25-hydroxyvitamin D concentration duri — View Citation

Helve O, Viljakainen H, Holmlund-Suila E, Rosendahl J, Hauta-Alus H, Enlund-Cerullo M, Valkama S, Heinonen K, Räikkönen K, Hytinantti T, Mäkitie 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. — View Citation

Holmlund-Suila E, Enlund-Cerullo M, Valkama S, Hauta-Alus H, Rosendahl J, Helve O, Hytinantti T, Viljakainen H, Andersson S, Mäkitie O. Sex and Iron Modify Fibroblast Growth Factor 23 (FGF23) Concentration in 1-Year-Old Children. J Clin Endocrinol Metab. — View Citation

Holmlund-Suila E, Viljakainen H, Hytinantti T, Lamberg-Allardt C, Andersson S, Mäkitie 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. — View Citation

Rosendahl J, Holmlund-Suila E, Helve O, Viljakainen H, Hauta-Alus H, Valkama S, Enlund-Cerullo M, Hytinantti T, Tervahartiala T, Sorsa T, Mäkitie O, Andersson S. 25-hydroxyvitamin D correlates with inflammatory markers in cord blood of healthy newborns. P — View Citation

Valkama S, Holmlund-Suila E, Enlund-Cerullo M, Rosendahl J, Hauta-Alus H, Helve O, Hytinantti T, Viljakainen H, Andersson S, Mäkitie O. No Severe Hypercalcemia with Daily Vitamin D3 Supplementation of up to 30 µg during the First Year of Life. Horm Res Pa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth	Measurement of growth at 2 years of age	2 years of age
Primary	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
Primary	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
Primary	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
Primary	Bone mineral density	Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography	2 years of age

External Links

•   Study web-page in Finnish