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

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.

Study Overview

• Status: Completed
• Conditions: Supplementation; Vitamin D
• Intervention / Treatment: Dietary supplement: cholecalciferol (D3); Dietary supplement: cholecalciferol (D3); Dietary supplement: cholecalciferol (D3)

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 Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Hospital for Children and Adolescents, Helsinki University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin D3 10µg	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
Active Comparator: Vitamin D3 30µg	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
Active Comparator: Vitamin D3 40µg	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki
• Investigators: Principal Investigator: Sture Andersson, MD, PhD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: January 12, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Estimate): July 18, 2011
• Last Update Submitted That Met QC Criteria: July 15, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: infant; cholecalciferol; bone mineral density
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: T1040D0038; 2009-015940-40 (EudraCT Number)