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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014