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Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
ergocalciferol 2000 IU orally, daily
ergocalciferol 25000 IU oraly every 2 weeks
ergocalciferol 50000 IU orally every 4 weeks
ergocal1000 IU & cholecal 1000 IU orally daily
cholecalciferol 2000 IU orally daily
Cholecalciferol 25000 IU orally every 2 weeks
Cholecalciferol 50000 orally every 4 weeks
placebo orally everyday
Sponsored by
King Faisal Specialist Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.
  • 25 OH vitamin D level between 20 to 50 nmol/L.

Sites / Locations

  • King Faisal Specialist Hospital & research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

D2 2000 IU daily

D3 2000 IU daily

D2 1000 IU + D3 1000 IU daily

D2 25000 IU Q2wk

D3 25000 IU Q2wk

D2 50000 IU Q4wk

D3 50000 IU Q4wk

placebo daily

Arm Description

Outcomes

Primary Outcome Measures

area under the curve of 25 OH vitamin D level
area under the curve of total 25 OH vitamin D level from day 1 to 140

Secondary Outcome Measures

Cmax of 25 OH vitamin D
Cmax of total 25 OH vitamin D over the treatment period of 140 days
Tmax of 25 OH vitamin D level
Tmax of total 25 OH vitamin D over the treatment period of 140 days
area under the curve of vitamin D level
area under the curve of total vitamin D level over 140 days
incidence of hypercalcemia
incidence of hypercalciuria

Full Information

First Posted
July 25, 2010
Last Updated
August 29, 2016
Sponsor
King Faisal Specialist Hospital & Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01170494
Brief Title
Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels
Official Title
Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Faisal Specialist Hospital & Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level. The investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D2 2000 IU daily
Arm Type
Active Comparator
Arm Title
D3 2000 IU daily
Arm Type
Active Comparator
Arm Title
D2 1000 IU + D3 1000 IU daily
Arm Type
Active Comparator
Arm Title
D2 25000 IU Q2wk
Arm Type
Active Comparator
Arm Title
D3 25000 IU Q2wk
Arm Type
Active Comparator
Arm Title
D2 50000 IU Q4wk
Arm Type
Active Comparator
Arm Title
D3 50000 IU Q4wk
Arm Type
Active Comparator
Arm Title
placebo daily
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ergocalciferol 2000 IU orally, daily
Other Intervention Name(s)
ergocalciferol
Intervention Description
ergocalciferol 2000 IU orally, daily
Intervention Type
Drug
Intervention Name(s)
ergocalciferol 25000 IU oraly every 2 weeks
Other Intervention Name(s)
ergocalciferol
Intervention Description
ergocalciferol 25000 IU oraly every 2 weeks
Intervention Type
Drug
Intervention Name(s)
ergocalciferol 50000 IU orally every 4 weeks
Other Intervention Name(s)
ergocalciferol
Intervention Description
ergocalciferol 50000 IU orally every 4 weeks
Intervention Type
Drug
Intervention Name(s)
ergocal1000 IU & cholecal 1000 IU orally daily
Other Intervention Name(s)
ergocalciferol and cholecalciferol
Intervention Description
ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day
Intervention Type
Drug
Intervention Name(s)
cholecalciferol 2000 IU orally daily
Other Intervention Name(s)
cholecalciferol
Intervention Description
cholecalciferol 2000 IU orally everyday
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol 25000 IU orally every 2 weeks
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Cholecalciferol 25000 IU orally every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol 50000 orally every 4 weeks
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Cholecalciferol 50000 orally every 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo orally everyday
Other Intervention Name(s)
placebo
Intervention Description
placebo orally everyday
Primary Outcome Measure Information:
Title
area under the curve of 25 OH vitamin D level
Description
area under the curve of total 25 OH vitamin D level from day 1 to 140
Time Frame
140 days
Secondary Outcome Measure Information:
Title
Cmax of 25 OH vitamin D
Description
Cmax of total 25 OH vitamin D over the treatment period of 140 days
Time Frame
140 days
Title
Tmax of 25 OH vitamin D level
Description
Tmax of total 25 OH vitamin D over the treatment period of 140 days
Time Frame
140 days
Title
area under the curve of vitamin D level
Description
area under the curve of total vitamin D level over 140 days
Time Frame
140 days
Title
incidence of hypercalcemia
Time Frame
140 days
Title
incidence of hypercalciuria
Time Frame
140 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids. 25 OH vitamin D level between 20 to 50 nmol/L.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad M Hammami, MD, PhD
Organizational Affiliation
King Faisal Specialist Hospital & Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Faisal Specialist Hospital & research Center
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
28231782
Citation
Hammami MM, Yusuf A. Differential effects of vitamin D2 and D3 supplements on 25-hydroxyvitamin D level are dose, sex, and time dependent: a randomized controlled trial. BMC Endocr Disord. 2017 Feb 24;17(1):12. doi: 10.1186/s12902-017-0163-9.
Results Reference
derived

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Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels

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