Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03035084
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center

Tracking Information
First Submitted Date  ICMJE January 15, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date August 13, 2018
Actual Study Start Date  ICMJE February 15, 2017
Actual Primary Completion Date November 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 [ Time Frame: day 28 ]
  • ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2 [ Time Frame: day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03035084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 [ Time Frame: day 56 ]
  • ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2 [ Time Frame: day 56 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?
Official Title  ICMJE Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Vitamin D Deficiency
  • 25-Hydroxyvitamin D Concentration
Intervention  ICMJE
  • Drug: Vitamin D3
    Single oral dose of 50,000 IU of vitamin D3
    Other Name: cholecalciferol
  • Drug: Vitamin D2
    Single oral dose of 50,000 IU of vitamin D2
    Other Name: Ergocalciferol
  • Drug: Placebo oral capsule
    Placebo oral capsule
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Vitamin D3
    • Drug: Vitamin D2
  • 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.
    Interventions:
    • Drug: Vitamin D2
    • Drug: 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.
    Intervention: Drug: Vitamin D2
  • 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.
    Intervention: Drug: Placebo oral capsule
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 20, 2017
Actual Primary Completion Date November 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035084
Other Study ID Numbers  ICMJE RAC2161235
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party King Faisal Specialist Hospital & Research Center
Study Sponsor  ICMJE King Faisal Specialist Hospital & Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muhammad M Hammami, MD, PhD King Faisal Specialist Hospital & Research Center (Riydah)
PRS Account King Faisal Specialist Hospital & Research Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP