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Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model

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ClinicalTrials.gov Identifier: NCT00779909
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Boston University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Gingivitis
Interventions: Drug: vitamin D3
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
102 potential participants were screened for study eligibility, 61 met various exclusions criteria, and 41 were found to be eligible for randomization. Of the 41 eligible subjects 35 were randomized into the trial. The 6 not randomized were either lost to follow-up or they lost interest and withdrew their consent for further involvement.

Reporting Groups
  Description
1- Placebo placebo oral supplementation once per day for 12 weeks
2- Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3- Vitamin D3 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4- Vitamin D3 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks

Participant Flow:   Overall Study
    1- Placebo   2- Vitamin D3, 500 IU   3- Vitamin D3 2500 IU   4- Vitamin D3 5000 IU
STARTED   10   9   8   8 
COMPLETED   9   8   8   7 
NOT COMPLETED   1   1   0   1 
Lost to Follow-up                1                0                0                1 
Withdrawal by Subject                0                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1-Placebo placebo oral supplementation once per day for 12 weeks
2-Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3-Vitamin D3, 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4-Vitamin D3, 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks
Total Total of all reporting groups

Baseline Measures
   1-Placebo   2-Vitamin D3, 500 IU   3-Vitamin D3, 2500 IU   4-Vitamin D3, 5000 IU   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   8   8   35 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      9 100.0%      8 100.0%      8 100.0%      35 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      5  50.0%      6  66.7%      7  87.5%      5  62.5%      23  65.7% 
Male      5  50.0%      3  33.3%      1  12.5%      3  37.5%      12  34.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
non-Hispanic Black   5   5   4   5   19 
Non-Hispanic White   5   4   4   3   16 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   10   9   8   8   35 


  Outcome Measures

1.  Primary:   Proportion of Sites That Bleed on Probing   [ Time Frame: end of 4 week experimental gingivitis phase ]

Measure Type Primary
Measure Title Proportion of Sites That Bleed on Probing
Measure Description Assessment of the bleeding index will be performed on oral and buccal sites. The periodontal probe will be moved gently across the marginal gingiva of all teeth of a quadrant. After 30 seconds, absence or presence of bleeding will be scored. The number of bleeding sites is used to calculate the gingival bleeding score.
Time Frame end of 4 week experimental gingivitis phase  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data for this outcome measure was not collected on any of the participants as it was overlooked and failure to collect these data did not come to the attention of the PI until after all follow-ups were completed.

Reporting Groups
  Description
1- Placebo placebo oral supplementation once per day for 12 weeks
2- Vitamin D3, 500 IU vitamin D3: oral supplementation once per day for 12 weeks
3.Vitamin D3, 2500 IU vitamin D3: oral supplementation once per day for 12 weeks
4- Vitamin D3 5000 IU vitamin D3: oral supplementation once per day for 12 weeks

Measured Values
   1- Placebo   2- Vitamin D3, 500 IU   3.Vitamin D3, 2500 IU   4- Vitamin D3 5000 IU 
Participants Analyzed   0   0   0   0 
Proportion of Sites That Bleed on Probing         

No statistical analysis provided for Proportion of Sites That Bleed on Probing



2.  Primary:   Mandibular Modified Gingival Index (MGI) Score   [ Time Frame: week 8 and week 12 ]

Measure Type Primary
Measure Title Mandibular Modified Gingival Index (MGI) Score
Measure Description The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
Time Frame week 8 and week 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1- Placebo placebo oral supplementation once per day for 12 weeks
2- Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3- Vitamin D3 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4- Vitamin D3 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks

Measured Values
   1- Placebo   2- Vitamin D3, 500 IU   3- Vitamin D3 2500 IU   4- Vitamin D3 5000 IU 
Participants Analyzed   9   8   8   7 
Mandibular Modified Gingival Index (MGI) Score 
[Units: Units on a scale]
Mean (Standard Deviation)
       
8wk mandibular MGI score   1.83  (0.27)   1.76  (0.46)   1.62  (0.44)   1.67  (0.28) 
12wk mandibular MGI score   2.12  (0.14)   1.97  (0.24)   2.02  (0.20)   2.19  (0.15) 

No statistical analysis provided for Mandibular Modified Gingival Index (MGI) Score



3.  Primary:   Maxillary Modified Gingival Index (MGI) Score   [ Time Frame: week 8 and week 12 ]

Measure Type Primary
Measure Title Maxillary Modified Gingival Index (MGI) Score
Measure Description The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
Time Frame week 8 and week 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1- Placebo placebo oral supplementation once per day for 12 weeks
2- Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3- Vitamin D3 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4- Vitamin D3 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks

Measured Values
   1- Placebo   2- Vitamin D3, 500 IU   3- Vitamin D3 2500 IU   4- Vitamin D3 5000 IU 
Participants Analyzed   9   8   8   7 
Maxillary Modified Gingival Index (MGI) Score 
[Units: Units on a scale]
Mean (Standard Deviation)
       
8wk maxillary MGI score   1.78  (0.29)   1.63  (0.40)   1.57  (0.39)   1.61  (0.31) 
12wk maxillary MGI score   2.11  (0.16)   1.87  (0.30)   1.9  (0.30)   2.1  (0.10) 

No statistical analysis provided for Maxillary Modified Gingival Index (MGI) Score



4.  Secondary:   Mandibular Plaque Index (PI) Score   [ Time Frame: week 8 and week 12 ]

Measure Type Secondary
Measure Title Mandibular Plaque Index (PI) Score
Measure Description The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual’s score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable.
Time Frame week 8 and week 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1- Placebo placebo oral supplementation once per day for 12 weeks
2- Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3- Vitamin D3 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4- Vitamin D3 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks

Measured Values
   1- Placebo   2- Vitamin D3, 500 IU   3- Vitamin D3 2500 IU   4- Vitamin D3 5000 IU 
Participants Analyzed   9   8   8   7 
Mandibular Plaque Index (PI) Score 
[Units: Units on a scale]
Mean (Standard Deviation)
       
8wk mandibular PI score   1.84  (0.60)   1.77  (0.44)   1.82  (0.46)   1.82  (0.57) 
12wk mandibular PI score   2.92  (0.71)   2.93  (0.50)   2.74  (0.52)   2.89  (0.32) 

No statistical analysis provided for Mandibular Plaque Index (PI) Score



5.  Secondary:   Maxillary Plaque Index (PI) Score   [ Time Frame: week 8 and week 12 ]

Measure Type Secondary
Measure Title Maxillary Plaque Index (PI) Score
Measure Description The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual’s score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable.
Time Frame week 8 and week 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1- Placebo placebo oral supplementation once per day for 12 weeks
2- Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3- Vitamin D3 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4- Vitamin D3 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks

Measured Values
   1- Placebo   2- Vitamin D3, 500 IU   3- Vitamin D3 2500 IU   4- Vitamin D3 5000 IU 
Participants Analyzed   9   8   8   7 
Maxillary Plaque Index (PI) Score 
[Units: Units on a scale]
Mean (Standard Deviation)
       
8wk maxillary PI score   1.56  (0.55)   1.71  (0.44)   1.69  (0.49)   1.68  (0.56) 
12 wk maxillary PI score   2.77  (0.42)   3  (0.32)   2.81  (0.32)   2.89  (0.47) 

No statistical analysis provided for Maxillary Plaque Index (PI) Score



6.  Secondary:   Gingival Crevicular Fluid (GCF) Volume   [ Time Frame: week 8 and week 12 ]

Measure Type Secondary
Measure Title Gingival Crevicular Fluid (GCF) Volume
Measure Description GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device. GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above.
Time Frame week 8 and week 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1-Placebo placebo oral supplementation once per day for 12 weeks
2-Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3-Vitamin D3, 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4-Vitamin D3, 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks

Measured Values
   1-Placebo   2-Vitamin D3, 500 IU   3-Vitamin D3, 2500 IU   4-Vitamin D3, 5000 IU 
Participants Analyzed   9   8   8   7 
Gingival Crevicular Fluid (GCF) Volume 
[Units: Ul]
Mean (Standard Deviation)
       
8wk GCF volume site 1   38.1  (12.5)   49.1  (21.3)   37.1  (10.0)   57.6  (24.2) 
12wk GCF volume site 1   50.8  (13.1)   66.5  (31.8)   35.1  (7.8)   55.9  (48.0) 
8wk GCF volume site 2   53.7  (9.8)   53.5  (23.4)   42.5  (27.4)   61.0  (36.0) 
12wk GCF volume site 2   83.6  (24.5)   71.9  (29.5)   54.3  (24.6)   72.4  (39.6) 
8wk GCF volume site 3   70.4  (32.9)   92.9  (26.0)   58.4  (19.7)   59.9  (16.5) 
12wk GCF volume site 3   95.9  (27.4)   99.1  (37.7)   64.8  (20.0)   92  (39.7) 

No statistical analysis provided for Gingival Crevicular Fluid (GCF) Volume



7.  Secondary:   Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12   [ Time Frame: week 8 and week 12 ]

Measure Type Secondary
Measure Title Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12
Measure Description

GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device.

GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above. Concentrations of TNF-alpha, IL-1 beta, IL-2, and IL-12 will be measured and means and SDs will be calculated for each study arm.

Time Frame week 8 and week 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1-Placebo placebo oral supplementation once per day for 12 weeks
2-Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3-Vitamin D3, 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4-Vitamin D3, 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks

Measured Values
   1-Placebo   2-Vitamin D3, 500 IU   3-Vitamin D3, 2500 IU   4-Vitamin D3, 5000 IU 
Participants Analyzed   9   8   8   7 
Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12 
[Units: Pg/site]
Mean (Standard Deviation)
       
8wk TNF-alpha   0.97  (1.14)   1.53  (1.86)   1.34  (1.93)   1.87  (3.14) 
12wk TNF-alpha   1.00  (1.04)   1.11  (1.32)   1.73  (3.02)   7.94  (18.12) 
8wk IL-1 beta   0.04  (0.00)   0.05  (0.02)   0.04  (0.00)   0.04  (0.00) 
12wk IL-1 beta   0.04  (0.00)   0.04  (0.02)   0.04  (0.00)   0.04  (0.00) 
8wk IL-2   24.11  (34.83)   13.44  (2.66)   13.13  (6.52)   13.07  (6.71) 
12wk IL-2   20.78  (17.31)   12.5  (0.00)   12.56  (0.18)   13.36  (1.70) 
8wk IL-12   0.65  (1.22)   0.11  (0.17)   0.03  (0.04)   0.96  (2.10) 
12wk IL-12   0.62  (1.10)   0.06  (0.07)   0.02  (0.01)   1.08  (2.28) 

No statistical analysis provided for Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12



8.  Secondary:   Serum Calcium   [ Time Frame: week 7, week 12 ]

Measure Type Secondary
Measure Title Serum Calcium
Measure Description The serum calcium blood test measures the total calcium in the participants' blood. The normal range for total serum calcium concentration in adults is 8.9-10.2 mg/dL.
Time Frame week 7, week 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1-Placebo placebo oral supplementation once per day for 12 weeks
2-Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3-Vitamin D3, 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4-Vitamin D3, 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks

Measured Values
   1-Placebo   2-Vitamin D3, 500 IU   3-Vitamin D3, 2500 IU   4-Vitamin D3, 5000 IU 
Participants Analyzed   9   8   8   7 
Serum Calcium 
[Units: Mg/dl]
Mean (Standard Deviation)
       
7wk serum calcium   9.6  (0.4)   9.1  (0.3)   9.2  (0.3)   9.1  (0.5) 
12wk serum calcium   9.4  (0.4)   9.2  (0.5)   9.2  (0.3)   9.3  (0.2) 

No statistical analysis provided for Serum Calcium



9.  Secondary:   Urinary Calcium/Creatinine Ratio   [ Time Frame: week 4, week 7, week 12 ]

Measure Type Secondary
Measure Title Urinary Calcium/Creatinine Ratio
Measure Description Urinary calcium ratios were calculated from urine samples at week 4, 7, and 12. A normal reference interval for the urine calcium (mg/dL):urine creatinine (mg/dL) ratio is <0.14.
Time Frame week 4, week 7, week 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1-Placebo placebo oral supplementation once per day for 12 weeks
2-Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3-Vitamin D3, 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4-Vitamin D3, 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks

Measured Values
   1-Placebo   2-Vitamin D3, 500 IU   3-Vitamin D3, 2500 IU   4-Vitamin D3, 5000 IU 
Participants Analyzed   9   8   8   7 
Urinary Calcium/Creatinine Ratio 
[Units: Ratio]
Mean (Standard Deviation)
       
4wk calcium/creatinine ratio   0.07  (0.1)   0.06  (0.03)   0.07  (0.04)   0.09  (0.01) 
7wk calcium/creatinine ratio   0.09  (0.1)   0.07  (0.04)   0.09  (0.02)   0.13  (0.13) 
12wk calcium/creatinine ratio   0.12  (0.1)   0.07  (0.03)   0.11  (0.09)   0.11  (0.07) 

No statistical analysis provided for Urinary Calcium/Creatinine Ratio




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were recruitment delays due to the potential seasonal impact on vitamin D levels from the sun and the research center was relocated. Both resulted in lower enrollment during the funded time frame than originally projected.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Raul I Garcia, DMD
Organization: Boston University School of Dental Medicine
phone: 617-638-6385
e-mail: rig@bu.edu



Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00779909     History of Changes
Other Study ID Numbers: H-26461
R21AT003714-01 ( U.S. NIH Grant/Contract )
First Submitted: October 22, 2008
First Posted: October 24, 2008
Results First Submitted: May 26, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017