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

King Faisal Specialist Hospital & Research Center

Status and phase: Completed; Phase 4

Conditions: 25-Hydroxyvitamin D Concentration; Vitamin D Deficiency

Treatments: Drug: Vitamin D2; Drug: Placebo oral capsule; Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT03035084

RAC2161235

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 4 patient groups, including a placebo group

Group-2-D3

Experimental group

Description:

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

Treatment:

Drug: Vitamin D3

Drug: Vitamin D2

Group-2-Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vitamin D2

Drug: Placebo oral capsule

Group-1-D2

Experimental group

Description:

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.

Treatment:

Drug: Vitamin D2

Group-1-Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo oral capsule