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

This study is currently recruiting participants.
Verified April 2013 by King Faisal Specialist Hospital & Research Center
Sponsor:
Information provided by (Responsible Party):
Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01170494
First received: July 25, 2010
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • area under the curve of 25 OH vitamin D level [ Time Frame: 140 days ] [ Designated as safety issue: No ]
    area under the curve of total 25 OH vitamin D level from day 1 to 140


Secondary Outcome Measures:
  • Cmax of 25 OH vitamin D [ Time Frame: 140 days ] [ Designated as safety issue: No ]
    Cmax of total 25 OH vitamin D over the treatment period of 140 days

  • Tmax of 25 OH vitamin D level [ Time Frame: 140 days ] [ Designated as safety issue: No ]
    Tmax of total 25 OH vitamin D over the treatment period of 140 days

  • area under the curve of vitamin D level [ Time Frame: 140 days ] [ Designated as safety issue: No ]
    area under the curve of total vitamin D level over 140 days

  • incidence of hypercalcemia [ Time Frame: 140 days ] [ Designated as safety issue: Yes ]
  • incidence of hypercalciuria [ Time Frame: 140 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: December 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170494

Contacts
Contact: Muhammad M Hammami, MD, PhD 966 1 442 4527 muhammad@kfshrc.edu.sa

Locations
Saudi Arabia
King Faisal Specialist Hospital & research Center Recruiting
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

No publications provided

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
Study First Received: July 25, 2010
Last Updated: April 8, 2013
Health Authority: Saudi Arabia:National Committee of Biological and Medical Ethics

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

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

ClinicalTrials.gov processed this record on May 22, 2013