Intervention: Cholecalciferol
Trial phase: Not Applicable
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 219
Group description: The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.

25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator.
Eligibility criteria:
Inclusion Criteria:

Males or females, 18-70 years of age and self-identified as African-American or Black
Pre-hypertension or hypertension (well controlled - see below)
If a potential study patient is not on treatment their SBP must be > 120 mmHg, or DBP > 80 mmHg
Whether on treatment or not SBP must be <160 mmHg and DBP must be < 100 mmHg (BP is not an outcome. Controlled BP is for participant safety)
Screening Vitamin D (D2 and D3 level) >5 and < 25 ng/ml (recommended normal level is > 30 ng/ml)
Body mass index (BMI) > 25 kg/m2 and < 45 kg/m2

Any female of non-childbearing potential, including any female who:

has had a hysterectomy,
has had a bilateral oophorectomy,
has had a bilateral tubal ligation or
is postmenopausal (demonstration of total cessation of menses for ≥ 1 year prior to the date of the screening visit)
Any female of child-bearing potential must agree to use at least one form of contraception (may be a barrier method), during the full duration of the study.

Exclusion Criteria:

Concurrent Disease:

Poorly controlled high blood pressure (SBP ≥160 mmHg or DBP ≥ 100 mmHg)
Poorly controlled diabetes (HbA1c >8.5%)
Screening Vitamin D (D2 and D3 level) < 5 or > 25 ng/ml (recommended normal level is > 30 ng/ml)
Estimated glomerular filtration rate (eGFR) < 45 ml/min
Evidence of disease that could result in hypercalcemia
History of kidney stones (less than one year prior to screening)
History of drug, alcohol, or illicit substance abuse (within the past 6 months)
History of another chronic disease which the investigator feels should preclude the subject from entering the study (e.g. cancer, immunologic disorder)
Liver function tests (LFTs) greater than twice the upper limit of normal
Subjects requiring chronic use of nonsteroidal anti-inflammatory drugs or aspirin >325 mg/day
Subjects requiring treatment with other vitamin D preparations containing more than 400 IU of vitamin D
Subjects requiring chronic use of immunosuppressive therapy or corticosteroids
Recent (<6 months) myocardial infarction, stroke, or hospitalization for congestive heart failure
Subjects with clinically apparent hypothyroidism or thyrotoxicosis
Allergy/intolerance: known allergy to oral vitamin D or microcrystalline cellulose
Any female of child-bearing potential who declines to use some method of birth control during the study period

Other:

Concurrent participation in other clinical trials or taking experimental medications or within 30 days of completing another trial or study.
Patients who are unable to give informed consent
Patients who, in the opinion of the Investigator, have a condition which would interfere with their evaluation (e.g. severe mental health disorder)
Patients who, in the opinion of the Investigator, may experience an unacceptable health risk by participating in this study
Patients who are pregnant or lactating
Not African- American or Black by self-identification
Body mass index (BMI) > 45 kg/m2