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Personalized Vitamin D Supplementation in European and African Americans

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vitamin D

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy, community-dwelling postmenopausal woman of self-reported European (Madison site) or African (Milwaukee site) descent
Able and willing to sign informed consent
Baseline serum 25(OH)D concentration of 10.0-29.9 ng/mL
Willing to not alter the amount of their baseline vitamin D supplementation during the course of this study
Willing to use sunscreen (SPF ≥15) when sun exposure of >15 minutes is expected during the months of May through September

Exclusion Criteria:

Diagnosis of kidney or liver disease (organs that metabolize vitamin D)
Current hypercalcemia (serum calcium ≥ 10.5 mg/dL) or other disorders that may affect vitamin D metabolism and predispose to hypercalcemia, i.e., sarcoidosis, active tuberculosis or other granulomatous disease.
Other chronic diseases or conditions potentially affecting vitamin D metabolism or absorption (inflammatory bowel disease, cystic fibrosis, ulcerative colitis, and malabsorptive surgery)
History of nephrolithiasis
Current use of medications that affect vitamin D metabolism (glucocorticoids, anticonvulsants, antifungals, and HIV/AIDS medications)
History of any form of cancer within the past two years with the exception of basal or squamous cell skin lesions, in situ tumors or thyroid cancer
Terminal illness/on hospice
Severe end-organ disease (e.g., cardiovascular, pulmonary, etc.), which may limit the ability to complete the study
Treatment with high dose vitamin D (≥50,000 IU weekly) or any active metabolites of vitamin D, e.g., calcitriol, within six months of screening; current use of multiple vitamins and other vitamin D supplements will be allowed.
Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer from May through September
Planned trips/vacations likely to be associated with substantial amounts of sun exposure during the course of the study (i.e., more than 500 miles south of Madison/Milwaukee)

Sites / Locations

University of Wisconsin Osteoporosis Clinical Research Program
Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Dosing Algorithm Group

Arm Description

The control group will receive 2500 IU of vitamin D3 daily.

The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.

Outcomes

Primary Outcome Measures

Efficacy of the Dosing Algorithm in Achieving Total 25(OH)D as Measured by the Percentage of Participants Ending With Concentrations of 35-50 ng/mL

To validate the proposed vitamin D3 dosing algorithm, a vitamin D panel consisting of serum concentrations of vitamin D3 (cholecalciferol; an indicator of vitamin D3 absorption), 25(OH)D3, 25(OH)D2, the C3-epimer of 25(OH)D3 and 24,25(OH)2D as well as an assay to directly measure free serum 25(OH)D will be run on all the blood samples collected at the baseline, 3 month and 6 month visits.

Secondary Outcome Measures

Full Information

NCT ID

NCT02362269

First Posted

January 22, 2015

Last Updated

November 13, 2020

Sponsor

University of Wisconsin, Madison

Collaborators

Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT02362269

Brief Title

Personalized Vitamin D Supplementation in European and African Americans

Official Title

Personalized Vitamin D Supplementation in European and African Americans

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

October 30, 2015 (Actual)

Primary Completion Date

May 3, 2019 (Actual)

Study Completion Date

May 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

Medical College of Wisconsin

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The proposed study is a randomized, double-blind, controlled, multi-center clinical trial of six months of daily oral vitamin D3 (cholecalciferol). This study will randomize 334 community-dwelling post-menopausal women of European and African descent (~167 from each ancestry) in a 1:1 ratio between the control arm and the dosing algorithm arm using stratified block randomization with a block size of six and stratification by site (ancestry). The sample size of 334 includes 10% over-recruitment to allow for loss to follow-up. The European ancestry women will be seen in the Madison clinic and the African ancestry women will be seen in the Milwaukee clinic. The proposed study will focus on post-menopausal women because this is the subset of the population that both Dr. Engelman's and Dr. Binkley's preliminary data are drawn from. Moreover, 25(OH)D concentrations are typically lower in women and in older individuals, since production of vitamin D in the skin following sun exposure decreases with age. Therefore, this group of individuals is likely to benefit the most from vitamin D supplementation, especially when personalized based on biology using the proposed dosing algorithm.

Detailed Description

Potential volunteers will be screened by telephone. Those meeting all inclusion and no exclusion criteria will be invited to a screening study visit. At screening, informed consent will be obtained. The study team will then collect the following to determine study eligibility: basic demographic information (age, ancestry, and education); medical history; medication and supplement use; and blood for screening 25(OH)D and calcium tests. At baseline, participants will be randomly assigned to the control or dosing algorithm group. Both participants and study staff who have contact with the participants will be blinded to group assignment. Follow-up visits will occur at three and six months. At baseline and follow-up visits, height and weight will be measured and blood will be drawn for the vitamin D panel, calcium, and PTH. Blood for DNA and body composition will only be obtained at the baseline visit. Participants will be asked to return all unused study supplements and compliance will be assessed at each follow-up visit by pill count. The control group will receive 2500 IU of vitamin D3 daily while the dosing algorithm group will initially receive 1000, 2500, or 4000 IU daily, with the initial dosing based on the 25(OH)D at baseline, and the dosing may be adjusted at the 3-month visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

169 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

The control group will receive 2500 IU of vitamin D3 daily.

Arm Title

Dosing Algorithm Group

Arm Type

Experimental

Arm Description

The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Intervention Description

Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.

Primary Outcome Measure Information:

Title

Efficacy of the Dosing Algorithm in Achieving Total 25(OH)D as Measured by the Percentage of Participants Ending With Concentrations of 35-50 ng/mL

Description

Time Frame

3 and 6 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy, community-dwelling postmenopausal woman of self-reported European (Madison site) or African (Milwaukee site) descent Able and willing to sign informed consent Baseline serum 25(OH)D concentration of 10.0-29.9 ng/mL Willing to not alter the amount of their baseline vitamin D supplementation during the course of this study Willing to use sunscreen (SPF ≥15) when sun exposure of >15 minutes is expected during the months of May through September Exclusion Criteria: Diagnosis of kidney or liver disease (organs that metabolize vitamin D) Current hypercalcemia (serum calcium ≥ 10.5 mg/dL) or other disorders that may affect vitamin D metabolism and predispose to hypercalcemia, i.e., sarcoidosis, active tuberculosis or other granulomatous disease. Other chronic diseases or conditions potentially affecting vitamin D metabolism or absorption (inflammatory bowel disease, cystic fibrosis, ulcerative colitis, and malabsorptive surgery) History of nephrolithiasis Current use of medications that affect vitamin D metabolism (glucocorticoids, anticonvulsants, antifungals, and HIV/AIDS medications) History of any form of cancer within the past two years with the exception of basal or squamous cell skin lesions, in situ tumors or thyroid cancer Terminal illness/on hospice Severe end-organ disease (e.g., cardiovascular, pulmonary, etc.), which may limit the ability to complete the study Treatment with high dose vitamin D (≥50,000 IU weekly) or any active metabolites of vitamin D, e.g., calcitriol, within six months of screening; current use of multiple vitamins and other vitamin D supplements will be allowed. Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer from May through September Planned trips/vacations likely to be associated with substantial amounts of sun exposure during the course of the study (i.e., more than 500 miles south of Madison/Milwaukee)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Corinne Engelman, PhD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin Osteoporosis Clinical Research Program

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

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Personalized Vitamin D Supplementation in European and African Americans

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