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NCT Number: NCT03035084

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

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

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Key information

Conditions

Vitamin D Deficiency 25-Hydroxyvitamin D Concentration Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Faisal Specialist Hospital & Research Center

Riyadh, Central, 11211, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

Single oral dose of 50,000 IU of vitamin D3

Other names: cholecalciferol

Vitamin D2

Drug

Single oral dose of 50,000 IU of vitamin D2

Other names: Ergocalciferol

Placebo oral capsule

Drug

Placebo oral capsule

Primary outcomes

  1. ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1

    Time frame: day 28

  2. ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2

    Time frame: day 28

Secondary outcomes

  1. ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1

    Time frame: day 56

  2. ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2

    Time frame: day 56

  3. Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level

    Time frame: day 28

  4. Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level

    Time frame: day 28

  5. Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group

    Time frame: day 28

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 27, 2017
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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