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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01170507
First received: July 25, 2010
Last updated: December 10, 2013
Last verified: December 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Slope of 25 OH vitamin D3 level vs vitamin D3 dose [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    slope of vitamin D3 level vs vitamin D3 dose over 5 months

  • incidence of hypercalcemia [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    incidence of hypercalcemia over 8 months

  • incidence of hypercalciuria [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    incidence of hypercalciuria over 8 months

  • slope of decline of 25 OH vitamin D3 level vs time [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    slope of decline of 25 OH vitamin D3 level vs time over 3 months


Estimated Enrollment: 1080
Study Start Date: December 2011
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 25, 2010
Last Updated: December 10, 2013
Health Authority: Saudi Arabia:National Committee of Biological and Medical Ethics

Keywords provided by 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
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014