Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-05 @ 12:49 AM
Study NCT ID:
NCT02362269
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2015-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Personalized Vitamin D Supplementation in European and African Americans
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Personalized Vitamin D Supplementation in European and African Americans
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: