Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study
Status:
Completed
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
Summary
Adequate levels of vitamin D are essential for bone health at all ages but low levels of
vitamin D may also negatively impact other aspects of health such as blood pressure. The
investigators have previously shown that adults with African ancestry living near the equator
have much higher levels of vitamin D and higher levels of blood pressure compared to adults
with African ancestry living in the Chicago area. Multiple clinical trials have examined
vitamin D supplementation for reducing blood pressure levels but very few studies have
focused on adults with African ancestry and low vitamin D levels. In addition, most previous
clinical trials have not addressed calcium intake. While vitamin D may modulate blood
pressure via its actions on activation of the renin angiotensin aldosterone system, it is
also possible that vitamin D mediates blood pressure via its effects on gastrointestinal
calcium absorption. This pilot study is a one arm study, which will assess the safety and
feasibility of supplementing 15 young adults with African ancestry and low vitamin D levels
with 5,000 IU of Cholecalciferol (vitamin D3) combined with 1000 mg of elemental calcium
daily for 3 months. Participants will be recruited from the Maywood Illinois and surrounding
areas with flyers and brochures. The investigators will also contact previous participants of
the Modeling the Epidemiologic Study/Vitamin D Ancillary Study by phone and letters. At
baseline, all participants will have blood pressure measured and will provide a fasting serum
specimen and a 24-hour urine collection. Calcium, parathyroid hormone level vitamin D will be
measured in serum specimens and 24-hour urine calcium excretion will be measured. Repeat
visits will be completed at 6 and 12 weeks of follow-up to again measure resting blood
pressure and serum calcium and vitamin D levels. The overall goal is to collect pilot data to
help design a larger trial of vitamin D and calcium supplementation for lowering blood
pressure in young adults with African ancestry.
Phase:
Phase 2
Details
Lead Sponsor:
Loyola University
Treatments:
Calcium, Dietary Cholecalciferol Ergocalciferols Vitamin D Vitamins