We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01275885
First Posted: January 13, 2011
Last Update Posted: July 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Helsinki University
Information provided by:
Helsinki University Central Hospital
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sture Andersson, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01275885     History of Changes
Other Study ID Numbers: T1040D0038
2009-015940-40 ( EudraCT Number )
First Submitted: January 12, 2011
First Posted: January 13, 2011
Last Update Posted: July 18, 2011
Last Verified: July 2011

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

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