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

This study has been completed.
Sponsor:
Collaborator:
Helsinki University
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01275885
First received: January 12, 2011
Last updated: July 15, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Vitamin D
Supplementation
 Dietary Supplement: cholecalciferol (D3)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D Intervention in Infants - Pilot

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • S-25OHD concentration after vitamin D supplementation to infants [ Time Frame: after 10 weeks of supplementation ] [ Designated as safety issue: No ]
    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:
  • concentration of calcium in the plasma and in the urine [ Time Frame: after 10 weeks of supplementation ] [ Designated as safety issue: Yes ]
    Incidence of hypercalcemia and hypercalciuria in infants after daily supplementation with vitamin D (10µg / 30µg / 40µg orally).

  • bone mineral density [ Time Frame: after 10 weeks of supplementation ] [ Designated as safety issue: No ]
    Measurement of bone mineral density using peripheral quantitative computed tomography (pQCT), after daily supplementation with vitamin D (10µg / 30µg / 40µg orally).


Enrollment: 113
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D3 10µg Dietary Supplement: cholecalciferol (D3)
10µg (400 IU) orally daily for 10 weeks
Active Comparator: Vitamin D3 30µg Dietary Supplement: cholecalciferol (D3)
30µg (1200 IU) orally daily for 10 weeks
Active Comparator: Vitamin D3 40µg Dietary Supplement: cholecalciferol (D3)
40µg (1600 IU) orally daily for 10 weeks

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy Caucasian women with an uneventful pregnancy
  • healthy infants born at term and appropriate for gestational age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275885

Locations
Finland
Hospital for Children and Adolescents, Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Helsinki University
Investigators
Principal Investigator: Sture Andersson, MD, PhD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Sture Andersson, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01275885     History of Changes
Other Study ID Numbers: T1040D0038, 2009-015940-40
Study First Received: January 12, 2011
Last Updated: July 15, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
cholecalciferol
infant
bone mineral density

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013