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

Phase 4

Completed

• Conditions: Vitamin D Deficiency; 25-Hydroxyvitamin D Concentration
• Interventions: Drug: Vitamin D3; Drug: Vitamin D2; Drug: Placebo oral capsule

• Registration Number: NCT03035084
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-15
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Study Start: 2017-02-15
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-20
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-2-Placebo	Placebo oral capsule	Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule.
Group-1-Placebo	Placebo oral capsule	Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule.
Group-2-D3	Vitamin D3	Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3
Group-2-Placebo	Vitamin D2	Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule.
Group-2-D3	Vitamin D2	Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3
Group-1-D2	Vitamin D2	Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2.

Primary Outcome Measures

Name	Time	Method
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2	day 28
ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1	day 28

Secondary Outcome Measures

Name	Time	Method
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
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
Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group	day 28
ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1	day 56
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2	day 56

Trial Locations

Locations (1)

King Faisal Specialist Hospital & Research Center; 🇸🇦 Riyadh, Central, Saudi Arabia