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

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ClinicalTrials.gov Identifier: NCT01170494
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: ergocalciferol 2000 IU orally, daily Drug: ergocalciferol 25000 IU oraly every 2 weeks Drug: ergocalciferol 50000 IU orally every 4 weeks Drug: ergocal1000 IU & cholecal 1000 IU orally daily Drug: cholecalciferol 2000 IU orally daily Drug: Cholecalciferol 25000 IU orally every 2 weeks Drug: Cholecalciferol 50000 orally every 4 weeks Drug: placebo orally everyday Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial
Study Start Date : February 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: D2 2000 IU daily Drug: ergocalciferol 2000 IU orally, daily
ergocalciferol 2000 IU orally, daily
Other Name: ergocalciferol
Active Comparator: D3 2000 IU daily Drug: cholecalciferol 2000 IU orally daily
cholecalciferol 2000 IU orally everyday
Other Name: cholecalciferol
Active Comparator: D2 1000 IU + D3 1000 IU daily Drug: ergocal1000 IU & cholecal 1000 IU orally daily
ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day
Other Name: ergocalciferol and cholecalciferol
Active Comparator: D2 25000 IU Q2wk Drug: ergocalciferol 25000 IU oraly every 2 weeks
ergocalciferol 25000 IU oraly every 2 weeks
Other Name: ergocalciferol
Active Comparator: D3 25000 IU Q2wk Drug: Cholecalciferol 25000 IU orally every 2 weeks
Cholecalciferol 25000 IU orally every 2 weeks
Other Name: Cholecalciferol
Active Comparator: D2 50000 IU Q4wk Drug: ergocalciferol 50000 IU orally every 4 weeks
ergocalciferol 50000 IU orally every 4 weeks
Other Name: ergocalciferol
Active Comparator: D3 50000 IU Q4wk Drug: Cholecalciferol 50000 orally every 4 weeks
Cholecalciferol 50000 orally every 4 weeks
Other Name: Cholecalciferol
Placebo Comparator: placebo daily Drug: placebo orally everyday
placebo orally everyday
Other Name: placebo


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. area under the curve of 25 OH vitamin D level [ Time Frame: 140 days ]
    area under the curve of total 25 OH vitamin D level from day 1 to 140


Secondary Outcome Measures :
  1. Cmax of 25 OH vitamin D [ Time Frame: 140 days ]
    Cmax of total 25 OH vitamin D over the treatment period of 140 days

  2. Tmax of 25 OH vitamin D level [ Time Frame: 140 days ]
    Tmax of total 25 OH vitamin D over the treatment period of 140 days

  3. area under the curve of vitamin D level [ Time Frame: 140 days ]
    area under the curve of total vitamin D level over 140 days

  4. incidence of hypercalcemia [ Time Frame: 140 days ]
  5. incidence of hypercalciuria [ Time Frame: 140 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01170494


Locations
Saudi Arabia
King Faisal Specialist Hospital & research Center
Riyadh, 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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Muhammad Maher Hammami, Chairman, Department of Clinical Studies & Empirical Ethics, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01170494     History of Changes
Other Study ID Numbers: RAC 2101041
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center:
vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
 Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents