- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03070483
Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study (BBC)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This pilot study will recruit 15 black U.S. adults ages 25-45 years of age with 25(OH)D levels < 20 ng/ml and no use of anti-hypertensive medications and a resting seated systolic blood pressure ≥ 120 mmHg and will measure baseline levels of total 25(OH)D, 25(OH)D2, 25(OH)D3, free vitamin 25(OH)D, active vitamin D [1,25(OH)D], parathyroid hormone level, serum calcium, and 24-hour calcium excretion.
Participants will then take the supplements vitamin D3 5000 IU and elemental calcium 1000 mg daily for three months. Investigators will measure changes in blood pressure, total 25(OH)D, 25(OH)D2 and 25(OH)D3, 1,25(OH)D and free 25(OH)D, parathyroid hormone levels, serum calcium and 24-hour urine calcium excretion over the three month period.
The overall goal is to collect pilot data to determine the feasibility of a larger trial to determine whether vitamin D combined with calcium lowers blood pressure in young black adults with low 25(OH)D levels.
This will be a single arm non-blinded feasibility study of 15 participants. The study population will consist of 15 adults ages 25-45 years with self-reported African American race/ethnicity. All participants will provide written informed consent.
Intervention:
This study has only one arm and all participants will receive Cholecalciferol (vitamin D3) 5,000 IU daily for 3 months and 1000 mg of calcium citrate daily for 3 months. There will be no placebo and no blinding of the agent. Participants will receive a 3 month supply of drugs which will be administered by the Loyola pharmacy. Serum vitamin D and calcium levels will be measured at study initiation and at 6 and 12 weeks (study end). Participants will stop taking stop both vitamin D and calcium administration with serum calcium levels are greater than or equal to 10.6 meq/L and/or a 25(OH)D levels are greater than or equal to 80 ng/dl at the 6 week visit.
Safety Monitoring:
The investigators will query any hospitalizations or emergency room visits over the past month and reasons for those visits at the baseline, 6 and 12 week follow-up visits. Serum calcium and vitamin D levels will be measured at 6 and 12 weeks and anyone with serum calcium levels ≥ 10.6 meq/L and/or a 25(OH)D level ≥ 80 ng/ml will stop treatment. All adverse events will be reported to the Loyola University Chicago Health Sciences Institutional Review Board. A data safety and monitoring board will review all data collected after completion of the 6 week visit to ensure safety of the study.
Stopping plans:
Any participant who develops a serum calcium levels ≥ 10.6 meq/L and/or a 25(OH)D level ≥ 80 ng/ml will stop treatment but they will continue to be monitored in the study through week 12 when serum calcium and 25(OH)D levels will be measured at the end of the study. The study will continue until participants have been followed for 12 weeks.
Analysis Plan:
This feasibility study will examine multiple aspects of the pilot data including the total number of persons enrolled vs. number of total persons identified as eligible. Pill counts will be done at the 6 and 12 week visit to assess compliance with vitamin D and calcium supplementation. The percentage of participants taking 80% or more of the vitamin D3 supplement and the calcium supplement will be determined. The number of participants reporting symptoms and all adverse events will be quantified. Repeated measures analysis of variance models will be used to assess change in the outcome measures including systolic and diastolic blood pressure, vitamin D measures, parathyroid hormone levels and 24-hour urine calcium excretion values.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Illinois
-
Maywood, Illinois, Forente stater, 60153
- Loyola Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Vitamin D
Participants will all receive supplementation with cholecalciferol 5000 IU and calcium citrate 1000 mg daily for 3 months
|
5000 IU cholecalciferol with 1000 mg calcium citrate daily
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Mean Blood Pressure From Baseline to 12 Weeks
Tidsramme: Difference in BP from baseline 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 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Total 25-hydroxyvitamin D From Baseline to 12 Weeks
Tidsramme: Change in total 25-hydroxyvitamin D level from baseline to 12 weeks after initiation of intervention
|
Total 25-hydroxyvitamin D will be measured with the use of liquid chromatography-tandem mass spectrometry
|
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
Tidsramme: 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).
|
Baseline and at 12 weeks after initiation of intervention
|
Change in Intact Parathyroid Hormone Levels From Baseline to 12 Weeks
Tidsramme: Change in PTH levels from 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
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Change in PTH levels from baseline and at 12 weeks after initiation of intervention
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Change in 1,25-dihydroxyvitamin D From Baseline to 12 Weeks
Tidsramme: Change in 1,25 dihydroxyvitamin D levels from 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
|
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
Tidsramme: Change in 24 hour urine calcium excretion from baseline and at 12 weeks after initiation of intervention
|
A 24-hour urine will be collected and calcium will be measured by Quest diagnostics
|
Change in 24 hour urine calcium excretion from baseline and at 12 weeks after initiation of intervention
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Holly Kramer, MD MPH, Loyola University Chicago
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 209476
Plan for individuelle deltakerdata (IPD)
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