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

Vitamin D Deficiency Clinical Trial

Official title:

Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170494
• Other study ID #: RAC 2101041
• Status: Completed
• Phase: N/A
• First received: July 25, 2010
• Last updated: August 29, 2016
• Start date: February 2013
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia:National Committee of Biological and Medical Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• ergocalciferol 2000 IU orally, daily
ergocalciferol 2000 IU orally, daily
• ergocalciferol 25000 IU oraly every 2 weeks
ergocalciferol 25000 IU oraly every 2 weeks
• ergocalciferol 50000 IU orally every 4 weeks
ergocalciferol 50000 IU orally every 4 weeks
• ergocal1000 IU & cholecal 1000 IU orally daily
ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day
• cholecalciferol 2000 IU orally daily
cholecalciferol 2000 IU orally everyday
• Cholecalciferol 25000 IU orally every 2 weeks
Cholecalciferol 25000 IU orally every 2 weeks
• Cholecalciferol 50000 orally every 4 weeks
Cholecalciferol 50000 orally every 4 weeks
• placebo orally everyday
placebo orally everyday

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital & research Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	area under the curve of 25 OH vitamin D level	area under the curve of total 25 OH vitamin D level from day 1 to 140	140 days	No
Secondary	Cmax of 25 OH vitamin D	Cmax of total 25 OH vitamin D over the treatment period of 140 days	140 days	No
Secondary	Tmax of 25 OH vitamin D level	Tmax of total 25 OH vitamin D over the treatment period of 140 days	140 days	No
Secondary	area under the curve of vitamin D level	area under the curve of total vitamin D level over 140 days	140 days	No
Secondary	incidence of hypercalcemia		140 days	Yes
Secondary	incidence of hypercalciuria		140 days	Yes