NCT01275885

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 18, 2011

Status Verified

July 1, 2011

Enrollment Period

9 months

First QC Date

January 12, 2011

Last Update Submit

July 15, 2011

Conditions

Vitamin DSupplementation

Keywords

cholecalciferolinfantbone mineral density

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • concentration of calcium in the plasma and in the urine

    after 10 weeks of supplementation

  • bone mineral density

    after 10 weeks of supplementation

Study Arms (3)

Vitamin D3 10µg

ACTIVE COMPARATOR
Dietary Supplement: cholecalciferol (D3)

Vitamin D3 30µg

ACTIVE COMPARATOR
Dietary Supplement: cholecalciferol (D3)

Vitamin D3 40µg

ACTIVE COMPARATOR
Dietary Supplement: cholecalciferol (D3)

Interventions

cholecalciferol (D3)DIETARY_SUPPLEMENT

10µg (400 IU) orally daily for 10 weeks

Vitamin D3 10µg

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Children and Adolescents, Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Sture Andersson, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 13, 2011

Study Start

August 1, 2010

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

July 18, 2011

Record last verified: 2011-07

Locations

FI(1)