Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study

NCT03070483 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 209476
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in Mean Blood Pressure From Baseline to 12 Weeks

  Seated blood pressure is measured at baseline and at 6 and 12 week follow-up visits in the clinic using an appropriate sized cuff after a rest period using an automated device (Omron). Blood pressure will be measured three times in one minute intervals at each time point and the average of these three recordings will be recorded as the mean blood pressure at each time point. Arm circumference will be measured to ensure the correct cuff size is used for all blood pressure measurements including home monitoring of blood pressure. Due to small number of participants, the change in mean blood pressure was analyzed as difference in mean blood pressure (2 x average diastolic blood pressure + average systolic blood pressure)/3 between baseline and at 12 weeks.

  Difference in BP from baseline and 12 weeks after initiation of intervention

Secondary Outcomes (5)

• Change in Total 25-hydroxyvitamin D From Baseline to 12 Weeks

  Change in total 25-hydroxyvitamin D level from baseline to 12 weeks after initiation of intervention

• Change in Free 25-hydroxyvitamin D Levels From Baseline to 12 Weeks

  Baseline and at 12 weeks after initiation of intervention

• Change in Intact Parathyroid Hormone Levels From Baseline to 12 Weeks

  Change in PTH levels from baseline and at 12 weeks after initiation of intervention

• Change in 1,25-dihydroxyvitamin D From Baseline to 12 Weeks

  Change in 1,25 dihydroxyvitamin D levels from baseline and at 12 weeks after initiation of intervention

• Change in 24-hour Urine Calcium Excretion From Baseline to 12 Weeks

  Change in 24 hour urine calcium excretion from baseline and at 12 weeks after initiation of intervention

Study Arms (1)

Vitamin D

EXPERIMENTAL

Participants will all receive supplementation with cholecalciferol 5000 IU and calcium citrate 1000 mg daily for 3 months

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

5000 IU cholecalciferol with 1000 mg calcium citrate daily

Also known as: Vitamin D3

Vitamin D

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25-45 years
• Self-reported race/ethnicity African American
• BMI ≥ 18 kg/m2
• Total 25(OH)D levels \< 20 ng/ml (50 nmol/L)
• No use of vitamin D supplements within past 30 days of the screening visit
• Able to provide written informed consent
• Willing to take a vitamin D supplement daily for 3 months
• Willing to return for follow-up visits to measure blood pressure and provide a blood sample to measure vitamin D and serum calcium
• No current use of blood pressure lowering medications
• Systolic blood pressure ≥ 100 mmHg and diastolic blood pressure ≥ 60 mmHg

You may not qualify if:

• Medical history of chronic disease that affect gastrointestinal absorption of vitamin D: Crohn's disease, cystic fibrosis, and celiac disease
• Use of medications which may affect total 25(OH)D levels: antiepileptic drugs, steroids, bile acid sequestrants, lipase inhibitors, orlistat
• Current use of vitamin D supplements or use in past month and unwillingness to discontinue for at least 1 month prior to study enrollment
• History of kidney stones or hypercalciuria
• Fasting serum calcium ≥ 10.2 mg/dl
• Average systolic blood pressure ≥ 140 mmHg
• Average diastolic blood pressure ≥ 90 mmHg
• Presence of type 1 diabetes mellitus, active malignancy, active thyroid disease or sarcoidosis
• Pregnant or planning a pregnancy
• Estimated glomerular filtration rate (based on serum creatinine level) is \< 60 ml/min/1.73 m2 based on the Modification of Diet in Renal Disease formula

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (1)

• Chiang D, Kramer H, Luke A, Cooper R, Aloia J, Bovet P, Plange-Rhule J, Forrester T, Lambert V, Camacho P, Dugas L, Durazo-Arvizu R. 25-Hydroxyvitamin D and blood pressure: a plateau effect in adults with African ancestry living at different latitudes. J Hypertens. 2017 May;35(5):968-974. doi: 10.1097/HJH.0000000000001263.

  PMID: 28118279 BACKGROUND

MeSH Terms

Conditions

Hypertension; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

We only enrolled 5 participants and 3 completed the trial. The early termination led to small number of subjects analyzed. We did not measure free vitamin D or 1,25 vitamin D levels.

Results Point of Contact

• Title: Dr. Holly Kramer
• Organization: Loyola University Chicago

hkramer@lumc.edu

7083279039

Study Officials

• Holly Kramer, MD MPH

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 3, 2017
• Study Start: March 25, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 24, 2020
• Results First Posted: June 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)