Clincosm LogoSign in Get a demo

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

Sponsor
King Faisal Specialist Hospital & Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT03035084
Collaborator
(none)
100
Enrollment
1
Location
4
Arms
9.1
Actual Duration (Months)
10.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin D3
  • Drug: Vitamin D2
  • Drug: Placebo oral capsule
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial
Actual Study Start Date :
Feb 15, 2017
Actual Primary Completion Date :
Nov 20, 2017
Actual Study Completion Date :
Nov 20, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group-2-D3

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

Drug: Vitamin D3
Single oral dose of 50,000 IU of vitamin D3
Other Names:
  • cholecalciferol

    • Drug: Vitamin D2
    Single oral dose of 50,000 IU of vitamin D2
    Other Names:
  • Ergocalciferol

    		•
    Placebo Comparator: Group-2-Placebo

    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.

    Drug: Vitamin D2
    Single oral dose of 50,000 IU of vitamin D2
    Other Names:
  • Ergocalciferol

    • Drug: Placebo oral capsule
    Placebo oral capsule
    Experimental: Group-1-D2

    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.

    Drug: Vitamin D2
    Single oral dose of 50,000 IU of vitamin D2
    Other Names:
  • Ergocalciferol

    		•
    Placebo Comparator: Group-1-Placebo

    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.

    Drug: Placebo oral capsule
    Placebo oral capsule

    Outcome Measures

    Primary Outcome Measures

    1. ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 [day 28]

    2. ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2 [day 28]

    Secondary Outcome Measures

    1. ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 [day 56]

    2. ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2 [day 56]

    3. Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level [day 28]

    4. Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level [day 28]

    5. Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group [day 28]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 King Faisal Specialist Hospital & Research Center Riyadh Central Saudi Arabia 11211

    Sponsors and Collaborators

    • King Faisal Specialist Hospital & Research Center

    Investigators

    • Principal Investigator: Muhammad M Hammami, MD, PhD, King Faisal Specialist Hospital & Research Center (Riydah)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    King Faisal Specialist Hospital & Research Center
    ClinicalTrials.gov Identifier:
    NCT03035084
    Other Study ID Numbers:
    • RAC2161235
    First Posted:
    Jan 27, 2017
    Last Update Posted:
    Aug 13, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    No Results Posted as of Aug 13, 2018