Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels - Full Text View

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:

MedlinePlus related topics: Dietary Supplements Vitamin D

Drug Information available for: Ergocalciferol Cholecalciferol Vitamin D

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 ]


Enrollment:	279
Study Start Date:	February 2013
Study Completion Date:	April 2016
Primary Completion Date:	April 2016 (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 (Adult)
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

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: 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


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:	August 29, 2016
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:


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 23, 2016