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Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?

Primary Purpose

Vitamin D Deficiency, 25-Hydroxyvitamin D Concentration

Status
Completed
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Vitamin D3
Vitamin D2
Placebo oral capsule
Sponsored by
King Faisal Specialist Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • non-pregnant adults (age ≥18 years)
  • healthy
  • total 25(OH)D level between 20 to 65 nmol/L.
  • living in Riyadh area

Exclusion criteria:

  • consumption of more than one serving of milk daily
  • taking vitamin D supplements
  • habitual weekly sun exposure of 10 hours or more
  • history of granulomatous, liver, or kidney disease
  • taking anticonvulsants, barbiturates, or steroids

Sites / Locations

  • King Faisal Specialist Hospital & Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Group-2-D3

Group-2-Placebo

Group-1-D2

Group-1-Placebo

Arm Description

Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3

Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule.

Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2.

Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule.

Outcomes

Primary Outcome Measures

ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2

Secondary Outcome Measures

ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level
Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level
Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group

Full Information

First Posted
January 15, 2017
Last Updated
August 9, 2018
Sponsor
King Faisal Specialist Hospital & Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03035084
Brief Title
Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?
Official Title
Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in 25(OH)D2 level. The investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, 25-Hydroxyvitamin D Concentration

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group-2-D3
Arm Type
Experimental
Arm Description
Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3
Arm Title
Group-2-Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule.
Arm Title
Group-1-D2
Arm Type
Experimental
Arm Description
Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2.
Arm Title
Group-1-Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
Single oral dose of 50,000 IU of vitamin D3
Intervention Type
Drug
Intervention Name(s)
Vitamin D2
Other Intervention Name(s)
Ergocalciferol
Intervention Description
Single oral dose of 50,000 IU of vitamin D2
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo oral capsule
Primary Outcome Measure Information:
Title
ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
Time Frame
day 28
Title
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
Time Frame
day 28
Secondary Outcome Measure Information:
Title
ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
Time Frame
day 56
Title
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
Time Frame
day 56
Title
Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level
Time Frame
day 28
Title
Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level
Time Frame
day 28
Title
Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group
Time Frame
day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: non-pregnant adults (age ≥18 years) healthy total 25(OH)D level between 20 to 65 nmol/L. living in Riyadh area Exclusion criteria: consumption of more than one serving of milk daily taking vitamin D supplements habitual weekly sun exposure of 10 hours or more history of granulomatous, liver, or kidney disease taking anticonvulsants, barbiturates, or steroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad M Hammami, MD, PhD
Organizational Affiliation
King Faisal Specialist Hospital & Research Center (Riydah)
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
State/Province
Central
ZIP/Postal Code
11211
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30658603
Citation
Hammami MM, Abuhdeeb K, Hammami S, Yusuf A. Vitamin-D2 treatment-associated decrease in 25(OH)D3 level is a reciprocal phenomenon: a randomized controlled trial. BMC Endocr Disord. 2019 Jan 18;19(1):8. doi: 10.1186/s12902-019-0337-8.
Results Reference
derived

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Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?

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