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Trial record 26 of 123 for:    hypertension "vitamin d"

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

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ClinicalTrials.gov Identifier: NCT03070483
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Holly J. Mattix-Kramer, Loyola University

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.

Condition or disease Intervention/treatment Phase
Hypertension Vitamin D Deficiency Drug: Cholecalciferol Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D
Participants will all receive supplementation with cholecalciferol 5000 IU and calcium citrate 1000 mg daily for 3 months
Drug: Cholecalciferol
5000 IU cholecalciferol with 1000 mg calcium citrate daily
Other Name: Vitamin D3




Primary Outcome Measures :
  1. Change in mean blood pressure from baseline to 12 weeks [ Time Frame: baseline and 6 and 12 weeks after initiation of intervention ]
    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. The average of these three recordings will be recorded as the mean blood pressure. Arm circumference will be measured to ensure the correct cuff size is used for all blood pressure measurements including home monitoring of blood pressure.


Secondary Outcome Measures :
  1. Change in total 25-hydroxyvitamin D from baseline to 12 weeks [ Time Frame: Baseline and at 6 and 12 weeks after initiation of intervention ]
    Total 25-hydroxyvitamin D will be measured with the use of liquid chromatography-tandem mass spectrometry

  2. Change in free 25-hydroxyvitamin D levels from baseline to 12 weeks [ Time Frame: Baseline and at 12 weeks after initiation of intervention ]
    Free 25(OH)D levels-will be measured using kits from Future Diagnostics (Wijchen, The Netherlands).

  3. Change in intact parathyroid hormone levels from baseline to 12 weeks [ Time Frame: Baseline and at 12 weeks after initiation of intervention ]
    Intact parathyroid hormone levels will be measured with the use of the Elecsys Parathyroid Hormone Immunoassay

  4. Change in 1,25-dihydroxyvitamin D from baseline to 12 weeks [ Time Frame: Baseline and at 12 weeks after initiation of intervention ]
    1,25 -dihydroxyvitamin D will be measured with the use of liquid chromatography-tandem mass spectrometry

  5. Change in 24-hour urine calcium excretion from baseline to 12 weeks [ Time Frame: Baseline and at 12 weeks after initiation of intervention ]
    A 24-hour urine will be collected and calcium will be measured by Quest diagnostics



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Medical history of chronic disease that affect gastrointestinal absorption of vitamin D: Crohn's disease, cystic fibrosis, and celiac disease
  2. Use of medications which may affect total 25(OH)D levels: antiepileptic drugs, steroids, bile acid sequestrants, lipase inhibitors, orlistat
  3. Current use of vitamin D supplements or use in past month and unwillingness to discontinue for at least 1 month prior to study enrollment
  4. History of kidney stones or hypercalciuria
  5. Fasting serum calcium ≥ 10.2 mg/dl
  6. Average systolic blood pressure ≥ 140 mmHg
  7. Average diastolic blood pressure ≥ 90 mmHg
  8. Presence of type 1 diabetes mellitus, active malignancy, active thyroid disease or sarcoidosis
  9. Pregnant or planning a pregnancy
  10. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070483


Locations
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United States, Illinois
Loyola Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
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Principal Investigator: Holly Kramer, MD MPH Loyola University Chicago

Publications:
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Responsible Party: Holly J. Mattix-Kramer, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03070483     History of Changes
Other Study ID Numbers: 209476
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Vitamin D Deficiency
Vitamin D
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents