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NCT03035084 Clinical Trial

Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?

Vitamin D Deficiency Clinical Trial

Official title:
Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03035084
Other study ID # RAC2161235
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 15, 2017
Est. completion date November 20, 2017

Study information
Verified date August 2018
Source King Faisal Specialist Hospital & Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in 25(OH)D2 level.

The investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 20, 2017
Est. primary completion date November 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- non-pregnant adults (age =18 years)

- healthy

- total 25(OH)D level between 20 to 65 nmol/L.

- living in Riyadh area

Exclusion criteria:

- consumption of more than one serving of milk daily

- taking vitamin D supplements

- habitual weekly sun exposure of 10 hours or more

- history of granulomatous, liver, or kidney disease

- taking anticonvulsants, barbiturates, or steroids

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin D3
Single oral dose of 50,000 IU of vitamin D3
• Vitamin D2
Single oral dose of 50,000 IU of vitamin D2
• Placebo oral capsule
Placebo oral capsule

Locations
Country Name City State
Saudi Arabia King Faisal Specialist Hospital & Research Center Riyadh Central

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 ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 day 28
Primary ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2 day 28
Secondary ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 day 56
Secondary ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2 day 56
Secondary Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level day 28
Secondary Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level day 28
Secondary Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group day 28
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