Trial Outcomes & Findings for Vitamin D for Sickle-cell Respiratory Complications (NCT NCT01443728)

NCT ID: NCT01443728

Last Updated: 2024-08-09

Results Overview

Defined as respiratory infection, acute asthma exacerbation, and acute chest syndrome.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: Up to 2 years
• Results posted on: 2024-08-09

Participant Flow

Participants were consented and then randomized. Only individuals who were randomized were included in the data analysis, so demographics are only available for the 62 randomized.

Only participants who were randomized (62) were included in the analysis of data.

Participant milestones

Measure	Vitamin D3 100,000 IU Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
Overall Study STARTED	31	31
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Vitamin D3 100,000 IU Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	0	2

Baseline Characteristics

Vitamin D for Sickle-cell Respiratory Complications

Baseline characteristics by cohort

Measure	Vitamin D3 100,000 IU n=31 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=31 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month	Total n=62 Participants Total of all reporting groups
Age, Continuous	9.9 years STANDARD_DEVIATION 4.0 • n=5 Participants	9.9 years STANDARD_DEVIATION 3.8 • n=7 Participants	9.9 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sickle-cell Type SS	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Sickle-cell Type SC	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sickle-cell Type Sb0 thalassemia	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sickle-cell Type Sb1 thalassemia	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Defined as respiratory infection, acute asthma exacerbation, and acute chest syndrome.

Outcome measures

Measure	Vitamin D3 100,000 IU n=31 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=31 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
Mean Annual Rate of Respiratory Events Baseline	3.91 events per year Standard Deviation 0.35	4.34 events per year Standard Deviation 0.35
Mean Annual Rate of Respiratory Events Year 1	3.34 events per year Standard Deviation 0.37	4.28 events per year Standard Deviation 0.36
Mean Annual Rate of Respiratory Events Year 2	1.54 events per year Standard Deviation 0.37	1.49 events per year Standard Deviation 0.37

SECONDARY outcome

Timeframe: 2 years

The overall mean serum 25-OHD concentration will be measured for both groups.

Outcome measures

Measure	Vitamin D3 100,000 IU n=31 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=31 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
Mean 25-Hydroxyvitamin D (25-OHD)	36.1 ng/mL Interval 14.0 to 38.0	19.1 ng/mL Interval 13.0 to 20.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

Percent predicted forced vital capacity will be calculated for both groups.

Outcome measures

Measure	Vitamin D3 100,000 IU n=28 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=30 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
Forced Vital Capacity (FVC) Year 2	85.0 Percentage of predicted FVC Standard Deviation 2.5	92.1 Percentage of predicted FVC Standard Deviation 2.5
Forced Vital Capacity (FVC) Baseline	85.5 Percentage of predicted FVC Standard Deviation 2.8	90.2 Percentage of predicted FVC Standard Deviation 2.3
Forced Vital Capacity (FVC) Year 1	85.2 Percentage of predicted FVC Standard Deviation 2.7	92.4 Percentage of predicted FVC Standard Deviation 2.3

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

Percent predicted forced expiratory volume in 1 second will be calculated for both groups.

Outcome measures

Measure	Vitamin D3 100,000 IU n=28 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=30 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
Forced Expiratory Volume (FEV) in 1 Second (FEV1) Baseline	80.4 Percentage of predicted FEV1 Standard Deviation 2.4	84.9 Percentage of predicted FEV1 Standard Deviation 2.3
Forced Expiratory Volume (FEV) in 1 Second (FEV1) Year 1	79.1 Percentage of predicted FEV1 Standard Deviation 2.7	85.3 Percentage of predicted FEV1 Standard Deviation 2.1
Forced Expiratory Volume (FEV) in 1 Second (FEV1) Year 2	78.9 Percentage of predicted FEV1 Standard Deviation 2.8	84.5 Percentage of predicted FEV1 Standard Deviation 2.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

The ratio of FEV1 to FVC will be calculated (in percentage).

Outcome measures

Measure	Vitamin D3 100,000 IU n=28 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=30 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
FEV1/FVC Ratio Year 2	82.2 ratio Standard Deviation 1.5	81.6 ratio Standard Deviation 1.2
FEV1/FVC Ratio Baseline	84.0 ratio Standard Deviation 1.5	83.3 ratio Standard Deviation 1.5
FEV1/FVC Ratio Year 1	82.6 ratio Standard Deviation 1.0	81.7 ratio Standard Deviation 1.3

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

Percent predicted forced expiratory flow (FEF) during expiration of 25 to 75% of the FVC will be calculated.

Outcome measures

Measure	Vitamin D3 100,000 IU n=28 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=30 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
FEF 25-75 Baseline	69.8 Percentage of predicted FEF Standard Deviation 5.2	68.8 Percentage of predicted FEF Standard Deviation 4.9
FEF 25-75 Year 1	62.9 Percentage of predicted FEF Standard Deviation 4.4	64.8 Percentage of predicted FEF Standard Deviation 4.3
FEF 25-75 Year 2	62.8 Percentage of predicted FEF Standard Deviation 4.4	65.6 Percentage of predicted FEF Standard Deviation 4.3

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

The ratio of residual volume (RV) to total lung capacity (TLC) will be calculated (in percentage).

Outcome measures

Measure	Vitamin D3 100,000 IU n=23 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=20 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
RV/TLC Ratio Baseline	26.9 Percent ratio Standard Deviation 1.3	25.1 Percent ratio Standard Deviation 1.6
RV/TLC Ratio Year 1	25.4 Percent ratio Standard Deviation 1.8	22.6 Percent ratio Standard Deviation 1.9
RV/TLC Ratio Year 2	22.8 Percent ratio Standard Deviation 1.6	21.8 Percent ratio Standard Deviation 1.9

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

Percent predicted of the diffusing capacity for carbon monoxide in the lungs (DLCO) will be measured.

Outcome measures

Measure	Vitamin D3 100,000 IU n=20 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=19 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
DLCO Baseline	68.0 Percentage predicted DLCO Standard Deviation 3.2	72.3 Percentage predicted DLCO Standard Deviation 3.9
DLCO Year 1	62.9 Percentage predicted DLCO Standard Deviation 3.2	67.8 Percentage predicted DLCO Standard Deviation 2.4
DLCO Year 2	68.1 Percentage predicted DLCO Standard Deviation 3.8	72.9 Percentage predicted DLCO Standard Deviation 2.9

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

Fractional exhaled nitric oxide (FeNO) will be measured in parts per billion (ppb).

Outcome measures

Measure	Vitamin D3 100,000 IU n=28 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=30 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
FeNO Year 1	20.5 parts per billion Standard Deviation 3.5	16.1 parts per billion Standard Deviation 2.1
FeNO Year 2	18.1 parts per billion Standard Deviation 2.7	16.4 parts per billion Standard Deviation 2.4
FeNO Baseline	19.3 parts per billion Standard Deviation 2.7	16.9 parts per billion Standard Deviation 2.1

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

Maximum inspiratory pressure (MIP) will be measured.

Outcome measures

Measure	Vitamin D3 100,000 IU n=23 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=19 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
MIP Baseline	69.1 cm of water Standard Deviation 5.6	59.9 cm of water Standard Deviation 5.3
MIP Year 1	78.7 cm of water Standard Deviation 6.1	80.4 cm of water Standard Deviation 6.3
MIP Year 2	77.4 cm of water Standard Deviation 5.0	74.6 cm of water Standard Deviation 4.7

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

Maximum expiratory pressure (MEP) will be measured.

Outcome measures

Measure	Vitamin D3 100,000 IU n=23 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=19 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
MEP Baseline	66.3 cm of water Standard Deviation 3.9	66.3 cm of water Standard Deviation 5.4
MEP Year 1	60.4 cm of water Standard Deviation 3.3	57.3 cm of water Standard Deviation 3.1
MEP Year 2	58.7 cm of water Standard Deviation 3.4	56.2 cm of water Standard Deviation 4.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

Muscle strength was measured by looking at hand-grip strength in the right hand.

Outcome measures

Measure	Vitamin D3 100,000 IU n=25 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=27 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
Hand-grip, Right Baseline	21.2 pounds of force Standard Deviation 3.2	16.9 pounds of force Standard Deviation 2.2
Hand-grip, Right Year 1	20.6 pounds of force Standard Deviation 3.0	16.6 pounds of force Standard Deviation 2.4
Hand-grip, Right Year 2	23.8 pounds of force Standard Deviation 4.1	17.4 pounds of force Standard Deviation 2.9

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

Muscle strength was measured by looking at hand-grip strength in the left hand.

Outcome measures

Measure	Vitamin D3 100,000 IU n=25 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=27 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
Hand-grip, Left Baseline	19.9 pounds of force Standard Deviation 3.4	16.0 pounds of force Standard Deviation 2.1
Hand-grip, Left Year 1	19.0 pounds of force Standard Deviation 3.4	13.6 pounds of force Standard Deviation 2.4
Hand-grip, Left Year 2	19.6 pounds of force Standard Deviation 3.6	15.8 pounds of force Standard Deviation 2.8

SECONDARY outcome

Timeframe: Up to 2 years

Population: Only includes participants who completed the assessment.

Muscle strength was measured by looking at hand-grip strength in the dominant hand.

Outcome measures

Measure	Vitamin D3 100,000 IU n=25 Participants Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=27 Participants Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
Hand-grip, Dominant Baseline	21.2 pounds of force Standard Deviation 3.2	17.1 pounds of force Standard Deviation 2.2
Hand-grip, Dominant Year 1	20.8 pounds of force Standard Deviation 3.0	17.3 pounds of force Standard Deviation 2.4
Hand-grip, Dominant Year 2	23.8 pounds of force Standard Deviation 4.1	18.1 pounds of force Standard Deviation 3.1

Adverse Events

Vitamin D3 100,000 IU

Serious events: 11 serious events

Other events: 26 other events

Deaths: 0 deaths

Vitamin D3 12,000 IU

Serious events: 6 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vitamin D3 100,000 IU n=31 participants at risk Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=31 participants at risk Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
General disorders Acute Chest Syndrome	19.4% 6/31 • Up to 2 years	16.1% 5/31 • Up to 2 years
General disorders Pain Syndrome (Grade 3 & 4)	22.6% 7/31 • Up to 2 years	16.1% 5/31 • Up to 2 years
Infections and infestations Mucosal Infection (Herpetic Gingivostomatitis)	0.00% 0/31 • Up to 2 years	3.2% 1/31 • Up to 2 years
Nervous system disorders Stroke	0.00% 0/31 • Up to 2 years	3.2% 1/31 • Up to 2 years
Gastrointestinal disorders Cholecystitis	3.2% 1/31 • Up to 2 years	0.00% 0/31 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	3.2% 1/31 • Up to 2 years	0.00% 0/31 • Up to 2 years
Blood and lymphatic system disorders Hypoxemia	3.2% 1/31 • Up to 2 years	0.00% 0/31 • Up to 2 years
General disorders Pneumonia	3.2% 1/31 • Up to 2 years	0.00% 0/31 • Up to 2 years
Blood and lymphatic system disorders Sepsis	3.2% 1/31 • Up to 2 years	0.00% 0/31 • Up to 2 years
Infections and infestations Varicella Zoster	3.2% 1/31 • Up to 2 years	0.00% 0/31 • Up to 2 years
Blood and lymphatic system disorders Cervical Lymphadenitis	0.00% 0/31 • Up to 2 years	3.2% 1/31 • Up to 2 years

Other adverse events

Measure	Vitamin D3 100,000 IU n=31 participants at risk Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month Experimental: Vitamin D3 100,000 IU: Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month	Vitamin D3 12,000 IU n=31 participants at risk Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month Active Comparator: Vitamin D3 12,000 IU: Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month
Blood and lymphatic system disorders Anemia	6.5% 2/31 • Up to 2 years	16.1% 5/31 • Up to 2 years
General disorders Pain Syndrome (Grade 1 or 2)	48.4% 15/31 • Up to 2 years	48.4% 15/31 • Up to 2 years
Gastrointestinal disorders Constipation	6.5% 2/31 • Up to 2 years	0.00% 0/31 • Up to 2 years
Blood and lymphatic system disorders Blood Bilirubin Increased	12.9% 4/31 • Up to 2 years	12.9% 4/31 • Up to 2 years
Blood and lymphatic system disorders Leukocytosis	0.00% 0/31 • Up to 2 years	6.5% 2/31 • Up to 2 years
Infections and infestations Acute Otitis Media	3.2% 1/31 • Up to 2 years	6.5% 2/31 • Up to 2 years
Injury, poisoning and procedural complications Injury	12.9% 4/31 • Up to 2 years	6.5% 2/31 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	12.9% 4/31 • Up to 2 years	6.5% 2/31 • Up to 2 years
Infections and infestations Upper Respiratory Infection	19.4% 6/31 • Up to 2 years	6.5% 2/31 • Up to 2 years
Infections and infestations Streptococcal Pharyngitis	6.5% 2/31 • Up to 2 years	16.1% 5/31 • Up to 2 years
General disorders Fever	22.6% 7/31 • Up to 2 years	12.9% 4/31 • Up to 2 years
General disorders Acute Chest Syndrome (Grade 1 & 2)	22.6% 7/31 • Up to 2 years	6.5% 2/31 • Up to 2 years
Infections and infestations Influenza A/B	16.1% 5/31 • Up to 2 years	12.9% 4/31 • Up to 2 years
General disorders Acute Pharyngitis	9.7% 3/31 • Up to 2 years	6.5% 2/31 • Up to 2 years
General disorders Seizure	0.00% 0/31 • Up to 2 years	6.5% 2/31 • Up to 2 years
Renal and urinary disorders Urinary Tract Infection	9.7% 3/31 • Up to 2 years	6.5% 2/31 • Up to 2 years
General disorders Headache	6.5% 2/31 • Up to 2 years	0.00% 0/31 • Up to 2 years

Additional Information

Gary Brittenham, MD

Columbia University

Phone: 212-305-7005

Email: gmb31@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place