NCT01275885

Vitamin D Intervention in Infants - Pilot

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Vitamin D
• Supplementation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cholecalciferol (D3)	10µg (400 IU) orally daily for 10 weeks
DIETARY_SUPPLEMENT	cholecalciferol (D3)	30µg (1200 IU) orally daily for 10 weeks
DIETARY_SUPPLEMENT	cholecalciferol (D3)	40µg (1600 IU) orally daily for 10 weeks

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2011-01-13
• Last updated: 2011-07-18

Locations

1 site across 1 country: Finland