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: August 29, 2016

Last verified: August 2016

History of Changes

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:

MedlinePlus related topics: Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

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 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


Ages Eligible for Study:	18 Years to 60 Years (Adult)
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


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:	August 29, 2016
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 Vitamins Vitamin D	Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 28, 2016

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