NCT03099759

Brief Summary

Analyze the amount of change in blood serum Vitamin D levels in patients of 3 different dosing groups and how their levels change over a 3 month period of time.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

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

June 27, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

March 23, 2017

Last Update Submit

June 20, 2017

Conditions

Vitamin D Deficiency

Keywords

Vitamin D Dosing RegimensBlood Serum 25(OH)D3 Levels

Outcome Measures

Primary Outcomes (1)

  • Vitamin D

    Effectiveness of various Vitamin D protocols on raising and maintaining blood serum 25(OH)D3 levels over a three month period from baseline to 3 months with participants blood draws at initial, week 2, week 6 and week 12 time frame.

    Three Months

Study Arms (3)

Vitamin Dose Group 100,000 Units

ACTIVE COMPARATOR

100,000 units Vitamin D2 one time only.

Dietary Supplement: Vitamin D

Vitamin Dose Group 100,000 Units D2

ACTIVE COMPARATOR

100,000 units vitamin D2 weekly for three months.

Dietary Supplement: Vitamin D

Vitamin Dose Group 50,000/2,000 D2/D3

ACTIVE COMPARATOR

50,000 units Vitamin D2 for 10 days followed by 2,000 units Vitamin D3 daily the remainder of the three month study period.

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

Vitamin D2/D3

Also known as: Ergocalciferol, cholecalciferol
Vitamin Dose Group 100,000 UnitsVitamin Dose Group 100,000 Units D2Vitamin Dose Group 50,000/2,000 D2/D3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low Vitamin D level

You may not qualify if:

  • Normal Vitamin D level, already taking Vitamin D, any form of steroids, weight-loss drugs, anti-tuberculosis drugs, high blood pressure drugs, high cholesterol drugs, endocrine disease, being treated for any form of cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin DErgocalciferolsCholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Damien Billow, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2017

First Posted

April 4, 2017

Study Start

June 27, 2016

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

June 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share