Supplementation, Vitamin D
Conditions
Keywords
cholecalciferol, infant, bone mineral density
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTcholecalciferol (D3)
10µg (400 IU) orally daily for 10 weeks
Sponsors
University of Helsinki
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* healthy Caucasian women with an uneventful pregnancy * healthy infants born at term and appropriate for gestational age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| S-25OHD concentration after vitamin D supplementation to infants | after 10 weeks of supplementation | The primary endpoint is the concentration of 25OHD in serum after daily supplementation with vitamin D (10µg / 30µg / 40µg orally). Vitamin D supplementation is given to infants from 2 weeks of age to 3 months of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| concentration of calcium in the plasma and in the urine | after 10 weeks of supplementation | Incidence of hypercalcemia and hypercalciuria in infants after daily supplementation with vitamin D (10µg / 30µg / 40µg orally). |
| bone mineral density | after 10 weeks of supplementation | Measurement of bone mineral density using peripheral quantitative computed tomography (pQCT), after daily supplementation with vitamin D (10µg / 30µg / 40µg orally). |
Countries
Finland
Outcome results
None listed