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Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170507
First Posted: July 27, 2010
Last Update Posted: August 31, 2016
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.
Information provided by (Responsible Party):
Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
  Purpose

Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known.

The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 months.


Condition Intervention Phase
Vitamin D Deficiency Drug: vitamin D3 1000 IU orally daily for 5 months Drug: vitamin D3 3000 IU orally daily for 5 months Drug: vitamin D3 5000 IU orally daily for 5 months Drug: Placebo orally daily for 5 months Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Slope of 25 OH vitamin D3 level vs vitamin D3 dose [ Time Frame: 5 months ]
    The primary endpoint is the slope of the dose (vitamin D3)- response (25 OH vitamin D3 level) curve for each cohort. The slope of the placebo group will be used to determine changes in 25 OH vitamin D3 levels that are not related to study intervention. The slope will be determined over 5 months.


Secondary Outcome Measures:
  • slope of vitamin D3 level vs vitamin D3 dose [ Time Frame: 5 months ]
    slope of vitamin D3 level vs vitamin D3 dose over 5 months

  • incidence of hypercalcemia [ Time Frame: 8 months ]
    incidence of hypercalcemia over 8 months

  • incidence of hypercalciuria [ Time Frame: 8 months ]
    incidence of hypercalciuria over 8 months

  • slope of decline of 25 OH vitamin D3 level vs time [ Time Frame: 3 months ]
    slope of decline of 25 OH vitamin D3 level vs time over 3 months


Estimated Enrollment: 1080
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamin D3 1000 IU Drug: vitamin D3 1000 IU orally daily for 5 months
Active Comparator: Vitamin D3 3000 IU Drug: vitamin D3 3000 IU orally daily for 5 months
Active Comparator: Vitamin D3 5000 IU Drug: vitamin D3 5000 IU orally daily for 5 months
Placebo Comparator: Placebo Drug: Placebo orally daily for 5 months

  Eligibility

Information from the National Library of Medicine

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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:

  • 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.
  • Individuals with with total 25 OH vitamin D level exceeding 100 nmol/l will be excluded from the study. Individuals with 25 OH vitamin D levels less than 20 nmol/L will be excluded from the placebo arm.
  Contacts and Locations
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): NCT01170507


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

Responsible Party: Muhammad Maher Hammami, Chairman, Department of Clinical Studies & Empirical Ethics, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01170507     History of Changes
Other Study ID Numbers: RAC 2101042
First Submitted: July 25, 2010
First Posted: July 27, 2010
Last Update Posted: August 31, 2016
Last Verified: August 2016

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

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