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

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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

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
Vitamin D Deficiency 25-Hydroxyvitamin D Concentration Drug: Vitamin D3 Drug: Vitamin D2 Drug: Placebo oral capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : February 15, 2017
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : November 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: cholecalciferol

Drug: Vitamin D2
Single oral dose of 50,000 IU of vitamin D2
Other Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 [ Time Frame: day 28 ]
  2. ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2 [ Time Frame: day 28 ]

Secondary Outcome Measures :
  1. ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 [ Time Frame: day 56 ]
  2. ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: day 28 ]
  5. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035084


Locations
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Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, Central, Saudi Arabia, 11211
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
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Principal Investigator: Muhammad M Hammami, MD, PhD King Faisal Specialist Hospital & Research Center (Riydah)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT03035084     History of Changes
Other Study ID Numbers: RAC2161235
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcifediol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents