Vitamin D Intervention in Infants - Pilot

Phase 4

Completed

• Conditions: Vitamin D; Supplementation
• Interventions: Dietary Supplement: cholecalciferol (D3)

• Registration Number: NCT01275885
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-15
• Last Update Posted: 2011-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 10µg	cholecalciferol (D3)	-
Vitamin D3 30µg	cholecalciferol (D3)	-
Vitamin D3 40µg	cholecalciferol (D3)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Hospital for Children and Adolescents, Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland