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

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

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; 25-Hydroxyvitamin D Concentration
• Intervention / Treatment: Drug: Placebo oral capsule; Drug: Vitamin D3; Drug: Vitamin D2

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Saudi Arabia
  • Central
    • Riyadh, Central, Saudi Arabia, 11211
      • King Faisal Specialist Hospital & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group-2-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	Drug: Vitamin D3; Single oral dose of 50,000 IU of vitamin D3; Other Names: cholecalciferol; Drug: Vitamin D2; Single oral dose of 50,000 IU of vitamin D2; Other Names: Ergocalciferol
PLACEBO_COMPARATOR: Group-2-Placebo; 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.	Drug: Placebo oral capsule; Placebo oral capsule; Drug: Vitamin D2; Single oral dose of 50,000 IU of vitamin D2; Other Names: Ergocalciferol
EXPERIMENTAL: Group-1-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.	Drug: Vitamin D2; Single oral dose of 50,000 IU of vitamin D2; Other Names: Ergocalciferol
PLACEBO_COMPARATOR: Group-1-Placebo; 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.	Drug: Placebo oral capsule; Placebo oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
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)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 and 25(OH)D2 level in the active arm of each group	day 28

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center
• Investigators: Principal Investigator: Muhammad M Hammami, MD, PhD, King Faisal Specialist Hospital & Research Center (Riydah)

Publications and helpful links

General Publications

• Hammami MM, Abuhdeeb K, Hammami S, Yusuf A. Vitamin-D2 treatment-associated decrease in 25(OH)D3 level is a reciprocal phenomenon: a randomized controlled trial. BMC Endocr Disord. 2019 Jan 18;19(1):8. doi: 10.1186/s12902-019-0337-8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2017
• Primary Completion (ACTUAL): November 20, 2017
• Study Completion (ACTUAL): November 20, 2017

Study Registration Dates

• First Submitted: January 15, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (ESTIMATE): January 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: RAC2161235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No