Individualized Response to Vitamin D Treatment Study

Not Applicable

Completed

• Conditions: Characteristics That Modify the Response to Cholecalciferol Treatment
• Interventions: Dietary Supplement: Vitamin D3; Drug: Placebo

• Registration Number: NCT02925195
• Lead Sponsor: University of Washington

Brief Summary

The goal of this clinical trial is to determine individual-level genetic and metabolic characteristics that modify the response to cholecalciferol treatment.

This study is double blind, parallel design, randomized clinical trial that will assess genetic and metabolic characteristics that modify the response to cholecalciferol treatment. . Eligible participants will be randomly assigned to receive cholecalciferol treatment (2,000 international units of cholecalciferol daily by mouth) or placebo in a 3:1 ratio for a total duration of 16-weeks. The planned sample size is 1,600. The primary aim of this study is to identify genetic polymorphisms, clinical characteristics, and biomarkers that modify the biologic response to vitamin D3 treatment, assessed by changes in serum concentrations of parathyroid hormone (PTH) and 1,25(OH)2D and urine calcium excretion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Study Start: 2017-01-11
• Primary Completion: 2021-11-30
• Study Completion: 2022-03-04
• Results First Submitted: 2023-09-18
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Results First Posted: 2023-11-02
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 666

Inclusion Criteria

1,600 participants from the Multi-Ethnic Study of Atherosclerosis (MESA) study who are returning for their scheduled 6th MESA study visit.

Participants will be recruited from four field centers: Wake Forest University, Winston-Salem, NC; Columbia University, New York, NY; Northwestern University, Evanston, IL; and Johns Hopkins University, Baltimore, MD.

Exclusion Criteria

1. Current use of >1,000 international units (IU) of cholecalciferol daily
2. Current use of any activated vitamin D product (calcitriol, paricalcitol, hectorol)
3. Known history of allergy or adverse reaction to vitamin D treatment
4. Known clinical history of primary hyperparathyroidism
5. Known clinical history of kidney stones within the previous 5 years
6. Current participation in another interventional study
7. Inability to provide written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment	Vitamin D3	-
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change in Serum 1,25(OH)2D Concentration	16 weeks
Change in Serum PTH Concentration	16 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure	16 weeks
Change in Serum Calcium Concentrations	16 weeks
Change in Urine Calcium Excretion	16 weeks	Urine calcium excretion estimated as spot urine calcium-creatinine ratio

Trial Locations

Locations (5)

Columbia Univeristy; 🇺🇸 New York, New York, United States

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States