Vitamin D Intervention in Infants - Pilot

Vitamin D Clinical Trial

— VIDI-P  

Official title:

Vitamin D Intervention in Infants - Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275885
• Other study ID #: T1040D0038
• Secondary ID: 2009-015940-40
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2011
• Last updated: July 15, 2011
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• healthy Caucasian women with an uneventful pregnancy

• healthy infants born at term and appropriate for gestational age

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Supplementation
• Vitamin D

Intervention

Dietary Supplement:
• cholecalciferol (D3)
10µg (400 IU) orally daily for 10 weeks
• cholecalciferol (D3)
30µg (1200 IU) orally daily for 10 weeks
• cholecalciferol (D3)
40µg (1600 IU) orally daily for 10 weeks

Locations

Country	Name	City	State
Finland	Hospital for Children and Adolescents, Helsinki University Central Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S-25OHD concentration after vitamin D supplementation to infants	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.	after 10 weeks of supplementation	No
Secondary	concentration of calcium in the plasma and in the urine	Incidence of hypercalcemia and hypercalciuria in infants after daily supplementation with vitamin D (10µg / 30µg / 40µg orally).	after 10 weeks of supplementation	Yes
Secondary	bone mineral density	Measurement of bone mineral density using peripheral quantitative computed tomography (pQCT), after daily supplementation with vitamin D (10µg / 30µg / 40µg orally).	after 10 weeks of supplementation	No