Trial Outcomes & Findings for To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans (NCT NCT02802449)
NCT ID: NCT02802449
Last Updated: 2019-02-15
Results Overview
Building upon our hypothesis above, this aim exploits the fact that the nuclear Vit-D Receptor (VDR) regulates parathyroid hormone (PTH) gene transcription. Therefore the plasma PTH level serves as a sensitive biomarker of the Vit-D nutri-genomic response. This aim will define the multivariate determinants (covariates such as age, BMI, baseline Vit-D level and dietary calcium) of the Vit-D-PTH level relationship (the primary outcome variable) in African-Americans. It is anticipated that the Vit-D supplementation trial will document a wide variance of Vit-D-PTH level relationships that will identify patients at the upper and lower quartiles of the distribution that are either 'nutrient-responsive' or 'nutrient-resistant'. These studies should help identify the 'clinical' characteristics of the sub-set of African-Americans that exhibit the poorest response to Vit-D supplementation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
330 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Placebo
The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Placebo
|
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
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.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
219
|
|
Overall Study
COMPLETED
|
102
|
202
|
|
Overall Study
NOT COMPLETED
|
9
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans
Baseline characteristics by cohort
| Measure |
Placebo
n=111 Participants
The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Placebo
|
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
n=219 Participants
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.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
111 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
219 participants
n=7 Participants
|
330 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Building upon our hypothesis above, this aim exploits the fact that the nuclear Vit-D Receptor (VDR) regulates parathyroid hormone (PTH) gene transcription. Therefore the plasma PTH level serves as a sensitive biomarker of the Vit-D nutri-genomic response. This aim will define the multivariate determinants (covariates such as age, BMI, baseline Vit-D level and dietary calcium) of the Vit-D-PTH level relationship (the primary outcome variable) in African-Americans. It is anticipated that the Vit-D supplementation trial will document a wide variance of Vit-D-PTH level relationships that will identify patients at the upper and lower quartiles of the distribution that are either 'nutrient-responsive' or 'nutrient-resistant'. These studies should help identify the 'clinical' characteristics of the sub-set of African-Americans that exhibit the poorest response to Vit-D supplementation.
Outcome measures
| Measure |
Placebo
n=111 Participants
The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Placebo
|
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
n=219 Participants
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.
|
|---|---|---|
|
Plasma PTH Level
Baseline
|
58.29 pg/ml
Standard Deviation 23.82
|
60.73 pg/ml
Standard Deviation 26.04
|
|
Plasma PTH Level
Week 6
|
57.88 pg/ml
Standard Deviation 22.23
|
54.05 pg/ml
Standard Deviation 26.12
|
PRIMARY outcome
Timeframe: Baseline and Week 6Outcome measures
| Measure |
Placebo
n=111 Participants
The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Placebo
|
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
n=219 Participants
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.
|
|---|---|---|
|
Vitamin D3 Level
Baseline
|
17.02 ng/ml
Standard Deviation 4.51
|
16.55 ng/ml
Standard Deviation 4.87
|
|
Vitamin D3 Level
Week 6
|
16.64 ng/ml
Standard Deviation 4.90
|
32.73 ng/ml
Standard Deviation 7.14
|
SECONDARY outcome
Timeframe: Baseline and Week 6Outcome measures
| Measure |
Placebo
n=111 Participants
The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Placebo
|
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
n=219 Participants
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.
|
|---|---|---|
|
Oxidative Stress Markers: Cysteine
Cysteine (Baseline)
|
253.5 umol/L
Standard Deviation 41.5
|
252.4 umol/L
Standard Deviation 35.6
|
|
Oxidative Stress Markers: Cysteine
Cysteine (Week 6)
|
249.0 umol/L
Standard Deviation 38.7
|
241.2 umol/L
Standard Deviation 32.8
|
SECONDARY outcome
Timeframe: Baseline and Week 6Outcome measures
| Measure |
Placebo
n=111 Participants
The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Placebo
|
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
n=219 Participants
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.
|
|---|---|---|
|
Oxidative Stress Markers: Homocysteine
Homocysteine (Baseline)
|
11.5 umol/L
Standard Deviation 3.3
|
11.9 umol/L
Standard Deviation 6.1
|
|
Oxidative Stress Markers: Homocysteine
Homocysteine (Week 6)
|
11.0 umol/L
Standard Deviation 3.0
|
11.8 umol/L
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline and Week 6Outcome measures
| Measure |
Placebo
n=111 Participants
The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Placebo
|
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
n=219 Participants
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.
|
|---|---|---|
|
Oxidative Stress Markers: GSH
GSH (Baseline)
|
4.1 umol/L
Standard Deviation 1.2
|
4.1 umol/L
Standard Deviation 1.1
|
|
Oxidative Stress Markers: GSH
GSH (Week 6)
|
3.6 umol/L
Standard Deviation 0.9
|
3.5 umol/L
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline and Week 6Outcome measures
| Measure |
Placebo
n=111 Participants
The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Placebo
|
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
n=219 Participants
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.
|
|---|---|---|
|
Oxidative Stress Markers: Isoprostane
Isoprostane (Baseline)
|
8298.6 pg/ml
Standard Deviation 8504.8
|
11914.9 pg/ml
Standard Deviation 17904.9
|
|
Oxidative Stress Markers: Isoprostane
Isoprostane (Week 6)
|
687.1 pg/ml
Standard Deviation 54460.2
|
9979.7 pg/ml
Standard Deviation 8630.1
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=111 participants at risk
The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Placebo
|
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
n=219 participants at risk
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.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.90%
1/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.00%
0/219 • Adverse events were collected throughout duration of study = 12 weeks.
|
Other adverse events
| Measure |
Placebo
n=111 participants at risk
The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Placebo
|
25 Hydroxy-Vitamin D3 or [25 (OH) D3]
n=219 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Elevated Blood Pressure
|
0.90%
1/111 • Number of events 2 • Adverse events were collected throughout duration of study = 12 weeks.
|
1.8%
4/219 • Number of events 5 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Renal and urinary disorders
Abnormal Lab Value
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Fractured Right Arm
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck Strain
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Right Leg Pain
|
0.90%
1/111 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.00%
0/219 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin Injury - Right Lower Extremity (Pre-Existing)
|
0.90%
1/111 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.00%
0/219 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 2 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain Exacerbation
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Chest Sprain
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 2 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Left Shoulder Muscle Strain
|
0.90%
1/111 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.00%
0/219 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck Muscle Cramp
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash on Bilateral Lower Extremity
|
0.00%
0/111 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.46%
1/219 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.90%
1/111 • Number of events 1 • Adverse events were collected throughout duration of study = 12 weeks.
|
0.00%
0/219 • Adverse events were collected throughout duration of study = 12 weeks.
|
Additional Information
Dr. David Martins
Charles Drew University of Medicine and Science
Phone: 323-568-3353
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place