Vitamin D Intervention in Infants - 6 Years Follow-up (VIDI2)

NCT04302987 | Completed

• 1 other identifier: Helsinki University
• Study Type: observational
• Target: 415
• Locations: 1 country
• Sites: 1

Brief Summary

Exposure to vitamin D intervention in early life may have permanent effects on physiology and metabolism. Bone growth and mineralization, development of immunity, body composition and brain structure and functioning may be affected. The importance of a long-term surveillance includes follow-up of both beneficial but also harmful effects of vitamin D. Vitamin D intervention in infants (VIDI) study was conducted in 2013-2016. VIDI study was a large randomized trial that aimed to evaluate effects of two vitamin D supplemental doses of daily 10 ug and 30 ug from the age 2 weeks until 2 years on bone strength, infections, immunity, allergy, atopy and asthma, neurologic and cognitive development, and genetic regulation of mineral homeostasis. Current study is a 6 Years Follow-up (VIDI2) study of the original VIDI trial. Our focuses of interest in the follow-up are: bone strength, growth pattern, body composition, and morbidity due to infections and allergic diseases, and the development of immunity. Further, in addition to more classical associates of vitamin D, our aim is to continue to follow-up children's neurocognitive development and mental health. We will also focus on the effect of vitamin D supplementation on occurrence of molar-incisor hypomineralization, dental caries, and oral immunity.

Conditions

Bone Strength; Growth; Body Composition; Infection; Allergic Diseases; Dental Health

Outcome Measures

Primary Outcomes (16)

• Areal bone mineral quantity

  Bone mineral quantity in milligrams per millimeter is measured by peripheral quantitative computed tomography (pQCT).

  6.5 years

• Volumetric bone mineral density

  Bone mineral density in milligrams per cubic centimeter is measured by pQCT.

  6.5 years

• Cross-sectional area of the bone

  Cross-sectional area of the bone in square millimeters is measured by pQCT.

  6.5 years

• Bone mineral quantity

  Bone mineral quantity in grams is measured by dual-energy X-ray absorptiometry (DXA).

  6.5 years

• Bone mineral density

  Bone mineral density in grams per centimeter squared is measured by DXA.

  6.5 years

• Serum intact parathyroid hormone

  Serum intact parathyroid hormone concentration is measured from blood samples with the blood gas analyzer ABL 90 FLEX or ABL 835 FLEX.

  6.5 years

• Plasma ionized calcium

  Plasma ionized calcium concentration is measured from blood samples with the blood gas analyzer ABL 90 FLEX or ABL 835 FLEX.

  6.5 years

• Plasma alkaline phosphatase

  Plasma alkaline phosphatase concentration is measured from blood samples with photometric methods.

  6.5 years

• Serum C-telopeptide of type I collagen

  Serum C-telopeptide of type I collagen is measured with competitive polyclonal antibody assay.

  6.5 years

• Plasma fibroblast growth factor 23

  Plasma intact and C-terminal fibroblast growth factor 23 is determined with enzyme-linked immunosorbent assay.

  6.5 years

• Morbidity due to infectious diseases

  Morbidity due to infectious diseases in frequencies and type are to be collected via questionnaires filled in by parents.

  6.5 years

• Morbidity due to allergic diseases

  Morbidity due to allergic diseases and symptoms are to be collected via questionnaires filled in by parents.

  6.5 years

• Weight

  Weight in kilograms is measured with a Seca 285 digital measuring station.

  6.5 years

• Height

  .Height in centimeters is measured with a Seca 285 digital measuring station

  6.5 years

• Fat mass

  Fat mass in kilograms based on ohms is measured by InBody bioelectrical impedance analysis.

  6.5 years

• Fat-free mass

  Fat-free mass in kilograms based on ohms is measured with InBody.

  6.5 years

Secondary Outcomes (16)

• High sensitivity C-reactive protein

  6.5 years

• Plasma matrix metalloproteinase 8

  6.5 years

• Gene variants

  6.5 years

• Epigenetic changes

  6.5 years

• Cognitive abilities

  6.5 years

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

In the original VIDI study the eligible infants were born at term (37 weeks and 0 days' to 42 weeks and 0 days' gestation), with a birth weight within 2 SDs of the mean for gestational age. Infants excluded were those requiring intravenous glucose, antibiotics, nasal continuous positive airway pressure treatment for more than 1 day, phototherapy for more than 3 days, or nasogastric tube feeding for more than 1 day and infants with seizures.

You may qualify if:

• All who participated in the original VIDI study until last study visit at the age of 2 years.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (1)

Children's Hospital

Helsinki, Finland

Location

Related Publications (2)

• 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

• 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

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, saliva

MeSH Terms

Conditions

Infections

Study Officials

• Sture Andersson, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Sture Andersson

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 10, 2020
• Study Start: November 1, 2019
• Primary Completion: December 15, 2021
• Study Completion: May 27, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Locations

FI (1)