NCT01139840

Brief Summary

Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 31, 2011

Status Verified

October 1, 2011

Enrollment Period

7 months

First QC Date

June 7, 2010

Last Update Submit

October 27, 2011

Conditions

Healthy

Keywords

vitamin D2vitamin D3ergocalciferolcholecalciferolvitamin D statusTo determine relative potency of vitamins D2 and D3 under conditions of continuous administrationTo determine change in vitamin D content of subcutaneous fat after 12 weeks' administration

Outcome Measures

Primary Outcomes (1)

  • AUC for increment in serum 25(OH)D

    12 weeks

Secondary Outcomes (1)

  • change in vitamin D content of subcutaneous fat

    12 weeks

Study Arms (2)

vitamin D2

ACTIVE COMPARATOR
Dietary Supplement: vitamin D2

vitamin D3

ACTIVE COMPARATOR
Dietary Supplement: vitamin D3

Interventions

vitamin D2DIETARY_SUPPLEMENT

Study Supplement

vitamin D2
vitamin D3DIETARY_SUPPLEMENT

Study Supplement

vitamin D3

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • willingness to withhold supplement use for duration of study
  • willingness to avoid sun exposure for duration of study

You may not qualify if:

  • vitamin D supplement use
  • conditions that affect vitamin D metabolism by the body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Related Publications (1)

  • Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.

    PMID: 21177785DERIVED

MeSH Terms

Interventions

ErgocalciferolsCholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Robert P Heaney, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 9, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

October 31, 2011

Record last verified: 2011-10

Locations

US(1)