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Vitamin D Intervention in Infants - Pilot (VIDI-P)

H

Helsinki University Central Hospital (HUCH)

Status and phase

Completed
Phase 4

Conditions

Supplementation
Vitamin D

Treatments

Dietary Supplement: cholecalciferol (D3)

Study type

Interventional

Funder types

Other

Identifiers

NCT01275885
T1040D0038
2009-015940-40 (EudraCT Number)

Details and patient eligibility

About

The aims of the present study are to evaluate the concentrations of vitamin D in the plasma and of calcium in the plasma and in the urine as well as to evaluate bone mineral density using peripheral quantitative computed tomography (pQCT), after supplementation of vitamin D with 30µg (1200 IU) and 40µg (1600 IU), in comparison with currently recommended supplementation of vitamin D with 10µg (400 IU). In this pilot study supplementation is given to infants from 2 weeks of age to 3 months of age.

Full description

Vitamin D deficiency is common around the world. In Finland vitamin D levels are low in all age groups. Especially infants are predisposed to vitamin D deficiency. Partly this is due to low exposure to sunlight but mainly it is due to low dietary intake of vitamin D. Vitamin D prophylaxis was introduced in Finland in the 1950´s to overcome rickets. However, the recommended dose has decreased from 50µg (2000 IU) in the 1960´s to 10µg (400 IU) from beginning of the 1990´s. The serum concentration of 25-hydroxyvitamin D (S-25OHD) is used as a marker of vitamin D status in the body. Although there is no consensus of optimal concentration of S-25OHD, it has been proposed that concentrations lower than 50 nmol/l indicate deficiency. According to recent findings on 25-OHD concentrations in Finnish children, currently recommended intake of vitamin D is inadequate.

Enrollment

113 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • healthy Caucasian women with an uneventful pregnancy
  • healthy infants born at term and appropriate for gestational age

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

113 participants in 3 patient groups

Vitamin D3 10µg
Active Comparator group
Treatment:
Dietary Supplement: cholecalciferol (D3)
Dietary Supplement: cholecalciferol (D3)
Dietary Supplement: cholecalciferol (D3)
Vitamin D3 30µg
Active Comparator group
Treatment:
Dietary Supplement: cholecalciferol (D3)
Dietary Supplement: cholecalciferol (D3)
Dietary Supplement: cholecalciferol (D3)
Vitamin D3 40µg
Active Comparator group
Treatment:
Dietary Supplement: cholecalciferol (D3)
Dietary Supplement: cholecalciferol (D3)
Dietary Supplement: cholecalciferol (D3)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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