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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03035084

Enrollment

100

Registered

2017-01-27

Start date

2017-02-15

Completion date

2017-11-20

Last updated

2018-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency, 25-Hydroxyvitamin D Concentration

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

Interventions

DRUGVitamin D3

Single oral dose of 50,000 IU of vitamin D3

DRUGVitamin D2

Single oral dose of 50,000 IU of vitamin D2

DRUGPlacebo oral capsule

Placebo oral capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026