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Vitamin D Intervention in Infants - Pilot

NCT01275885 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2011-07-18

No results posted yet for this study

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.

Conditions

  • Vitamin D
  • Supplementation

Interventions

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

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Sture Andersson, MD, PhD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-05-31
Completion
2011-06-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01275885 on ClinicalTrials.gov