Metadata Catalog

Study Detail

Study ID	1023
Name	Comprehensive Sickle Cell Centers' (CSCC) -Arginine Supplementation in Sickle Cell Anemia: Physiological and Prophylactic Effects
Contact Email	lstyles@mail.cho.org
Acronym	CSCC-Arginine
Period	2004 - 2007
Design	Clinical Trial
Study PI	Lori Styles
Institution	Childrens Hospital of Oakland and Research Institute
URL	https://clinicaltrials.gov/ct2/show/NCT00513617
CTGovID	https://clinicaltrials.gov/ct2/show/NCT00513617
Funding Agency	NHLBI
Grant Number	5U54HL070587-04

Overview	Nitric oxide is an important inflammatory mediator produced from arginine by nitric oxide synthase.Nitric oxide has a multitude of functions which could impact favorably on vaso-occlusion in sickle cell disease.Oral arginine has been shown to raise levels of nitric oxide. This study will test whether daily oral arginineresults in an increase in nitric oxide and other beneficial effects in patients with sickle cell disease. The results ofthis study will serve as the basis for further clinical trials to determine if daily arginine is a beneficial therapy forpatients with sickle cell disease.
Focus Areas	1. To assess the physiological effects (both beneficial and deleterious) of the administrationof oral arginine in patients with SCD. 2. To evaluate the effect of daily oral arginine on clinical vaso-occlusive events in SCDpatients.
Outcomes	1. Efficacy will be determined by changes in three laboratory parameters which will serve assurrogates for potential clinical benefit: nitric oxide, Gardos channel activity, and RBC density. 2. sVCAM, Nitrotyrosine, 8-iso-PGF2a, Ektacytometry, endothelin-1, fetal hemoglobin (HbF) and echocardiogram results as well as clinical outcomes including hospitalizations, ER visits, and painmedication use.

Data Location	RTI International
Biospecimen Available	Blood; Plasma; Serum; Urine;
Data Consent	Consent describes the extent to which confidentiality of records identifying the volunteer will be maintained.
Biospecimen Consent	NA
Contact Consent	NA
Genomic Data	No

Age Range	5-99
No. Participants	128
Inclusion Criteria	History of at least one pain event in last 12 months
Exclusion Criteria	Major organ dysfunction, treatment with hydroxyurea or transfusion within 3months, history of recent priapism or retinopathy, pregnancy.

Study Documentation Select All	1. 2007April02_ArginineProtocolVersion6.0_CLEAN 2. Arginine Study Summary 3. 2006January_Arginine Training Manual 4. AE_R_DataSpecs_2009_07_08_11_23 5. CMED_R_DataSpecs_2009_07_08_11_23 6. Patient_R_DataSpecs_2009_07_08_11_23 7. VISIT_R_DataSpecs_2009_07_08_11_52
Forms Select All	Guidelines16FEB2006

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Clinical status (63)

Behavior (0)

Blood (2)

Data Element	Variables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease	Diagnosis Diagnosis

Cancer (0)

Cardiovascular (0)

Digestive (0)

Endocrine (0)

Family MedHx (0)

General Health (0)

Genitourinary (2)

Data Element	Variables
Genitourinary Problem	IHX_BLDURINE
Kidney Problem
Priapism	IHX_PAINERC
Renal Dialysis History

Immune (1)

Data Element	Variables
Fever	IHX_FEVER
HIV Infection
Immune Problem
Infection
Vaccination

Lymphatic (0)

Medical Event (21)

Data Element	Variables
Adverse event	Action_DoseAdjust Action_DrugDiscon Action_DrugInterrupt Action_Hospital Action_MedIntervention Action_None AE_End_Day AE_Start_Day AEText Continuing Death IHX_AES LowLevelName Outcome Preferred_Term Relationship Severity System_Organ_Class TEAE TRAE
Death
Disability Status
Hospitalization
Medical Event
Serious Adverse Event	SAE

Medical History (30)

Data Element	Variables
Medical History	EMRMNUM ENUMS FOLICD_1 FOLICYN HNUMS HOMENUM HONUMS HOSPNUM HYDROD_1 HYDROYN IHX_HEAD_FREQ IHX_PHIPS IHX_POTH NARCD_1 NARCYN NSAIDD_1 NSAIDYN NUMCCS NUMUNIT OPAIN1D_1 OPAIN2D_1 OPAINYN OTANTD_1 OTANTYN OTMEDD_1 OTMEDYN OXYGD_1 OXYGYN PPENCD_1 PPENCYN

Mental Health (0)

Musculoskeletal (0)

Neurodevelopmental (0)

Neurologic (0)

Nutritional and Metabolic (0)

Ocular (0)

Oral (0)

Pain (4)

Data Element	Variables
Abdominal Pain
General Pain
Headache	IHX_HEADACHE
Management	DNUMS DTOFNUM
Pain Attack	Days_to_Pain1
Skeletal and Joint Pain

Reproductive (0)

Respiratory (1)

Data Element	Variables
Acute Chest Syndrome
Asthma	IHX_BREATH
Lung Disease
Other Respiratory Problem

Skin (1)

Data Element	Variables
Skin Problem	IHX_LEGULCERS

Sleep (1)

Data Element	Variables
Sleep Problem	IHX_TIRED

Surgery History (0)

COVID-19 (0)

Diagnosis (0)

Impact (0)

Treatment (0)

Vaccination (0)

Demographics (4)

Data Element	Variables
Address
Age	Age_Group Age_trunc
Ethnic Group
Gender	Gender
Language
National Origin
Nuclear Family
Race	Af_Amer

Social Determinants of Health (SDoH) (0)

Socioeconomic Status (0)

Environmental Exposure (0)

Exposure (0)

Health Care (19)

Acute Care Utilization (11)

Data Element	Variables
Facility Type
Provider Type
Quality of Care
Visit	BS_CLIN BS_ED BS_ED_ACS BS_ED_OTH BS_ED_PAIN BS_ED_VOC Days_to_ED1 TE_EDTOT TE_EDYN TE_PainTOT TE_PainYN

Healthcare utilization (0)

Health Services (0)

Hospitalization (8)

Data Element	Variables
Final Diagnosis
Hospitalization	Days_to_Hosp1 BS_HOSP BS_HOSP_ACS BS_HOSP_OTH BS_HOSP_PAIN BS_HOSP_VOC TE_HospTOT TE_HospYN
ICU

SCD Management (0)

Imaging (34)

Angiogram (0)

Catheterization (0)

CT Scan (0)

Echocardiogram (34)

Data Element	Variables
Echocardiogram	AB_ECHO_DAY ABEFRAC ABENOT ABJETUN ABLVH ABRVH ABSFRAC ABSTNOT ABTRJET APNOT ARVTRAD BaseEJFRACT BaseRVTRAD BaseSTFRACT BaseTRJET BaseWidth ChangeBaseEJFRACT ChangeBaseRVTRAD ChangeBaseSTFRACT ChangeBaseTRJET ECHO_ABNORM ECHOABN EJFRACT EJNOT PANOT PChangeBaseEJFRACT PChangeBaseRVTRAD PChangeBaseSTFRACT PChangeBaseTRJET RVTRAD STFRACT STNOT TRJET TRJETUN

Electrocardiogram (ECG) (0)

Electrodiagnosis (0)

General Imaging (0)

MRI/MRA (0)

Nuclear Medicine Imaging (0)

PET scan (0)

Transcranial Doppler (TCD) (0)

Ultrasound (0)

X-Ray (0)

Parent/Caretaker (0)

Demographics (0)

Psychosocial (0)

Quality of Life (0)

General Health (0)

Pain (0)

Patient Functioning (0)

SCD (0)

Tests (313)

Biopsy (0)

Blood (306)

Data Element	Variables
Blood Differential Test
Blood Gases	BaseCO2 BaseCO2_NA ChangeBaseCO2 CO2 CO2_NA CO2High CO2Low NOX ShiftCO2 WorstCO2_NA
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count	A_ARETICCNT A_CH A_CHCM A_GARDOS A_HCT A_HGB A_HGB_HIGH A_HGB_ORIGINAL A_M_CHCM A_M_MCV A_MCH A_MCHC A_MCV A_PercbA A_PHYPER A_RBC A_WBC AbsReticCnt AbsReticCnt_NA AbsReticCntHigh AbsReticCntLow ALKPHOSPH_NORM1 BaseA_CH BaseA_CHCM BaseA_HCT BaseA_HGB BaseA_M_CHCM BaseA_M_MCV BaseA_MCH BaseA_MCHC BaseA_MCV BaseA_RBC BaseA_WBC BaseAbsReticCnt BaseAbsReticCnt_NA BaseHematocrit BaseHematocrit_NA BaseHemoglobin BaseHemoglobin_NA BaseMCHC BaseMCHC_NA BaseMCV BaseMCV_NA BaseMetHb BaseMetHb_NA BasePercRetic BasePercRetic_NA BasePlateletCnt BasePlateletCnt_NA BaseRBC BaseRBC_NA BaseWBC BaseWBC_NA CF_HGB ChangeBaseA_AReticCnt ChangeBaseA_CH ChangeBaseA_CHCM ChangeBaseA_HCT ChangeBaseA_HGB ChangeBaseA_M_CHCM ChangeBaseA_M_MCV ChangeBaseA_MCH ChangeBaseA_MCHC ChangeBaseA_MCV ChangeBaseA_Pretic ChangeBaseA_RBC ChangeBaseA_WBC ChangeBaseAbsReticCnt ChangeBaseHematocrit ChangeBaseHemoglobin ChangeBaseMCHC ChangeBaseMCV ChangeBaseMetHb ChangeBasePercRetic ChangeBaseRBC ChangeBaseWBC Hematocrit Hematocrit_NA HEMATOCRIT_NORM1 HEMATOCRIT_NORM2 HEMATOCRIT_NORM3 HEMATOCRIT_NORM4 HematocritHigh HematocritLow Hemoglobin Hemoglobin_NA HemoglobinHigh HemoglobinLow MCHC MCHC_NA MCHC_NORM1 MCHC_NORM2 MCHC_NORM3 MCHC_NORM4 MCHCHigh MCHCLow MCV MCV_NA MCV_NORM1 MCV_NORM2 MCV_NORM3 MCV_NORM4 MCVHigh MCVLow MetHb MetHb_Day MetHb_NA MetHbHigh MetHbLow PChangeBaseA_AReticCnt PChangeBaseA_CH PChangeBaseA_CHCM PChangeBaseA_HCT PChangeBaseA_HGB PChangeBaseA_M_CHCM PChangeBaseA_M_MCV PChangeBaseA_MCH PChangeBaseA_MCHC PChangeBaseA_MCV PChangeBaseA_Pretic PChangeBaseA_RBC PChangeBaseA_WBC PercRetic PercRetic_NA PercReticHigh PercReticLow PlateletCnt PlateletCnt_NA PlateletCntHigh PlateletCntLow RBC RBC_NA RBCHigh RBCLow ShiftAbsReticCnt ShiftHematocrit ShiftHemoglobin ShiftMCHC ShiftMCV ShiftMetHb ShiftPercRetic ShiftPlateletCnt ShiftRBC ShiftWBC WBC WBC_NA WBCHigh WBCLow WorstAbsReticCnt_NA WorstHematocrit_NA WorstHemoglobin_NA WorstMCHC_NA WorstMCV_NA WorstMetHb_NA WorstPlateletCnt_NA WorstRBC_NA WorstWBC_NA
Comprehensive Metabolic Panel (CMP)	Albumin Albumin_NA AlbuminHigh AlbuminLow AlkPhosph AlkPhosph_NA ALKPHOSPH_NORM2 ALKPHOSPH_NORM3 ALKPHOSPH_NORM4 AlkPhosphHigh AlkPhosphLow ALT ALT_LLOD ALT_NA ALTHigh ALTLow BaseAlbumin BaseAlbumin_NA BaseAlkPhosph BaseAlkPhosph_NA BaseALT BaseALT_NA BaseBUN BaseBUN_NA BaseCalcium BaseCalcium_NA BaseChloride BaseChloride_NA BaseCreatinine BaseCreatinine_NA BaseGlucose BaseGlucose_NA BasePotassium BasePotassium_NA BaseSodium BaseSodium_NA BaseTotBilirubin BaseTotBilirubin_NA BaseTotProtein BaseTotProtein_NA BUN BUN_LLOD BUN_NA BUNHigh BUNLow Calcium Calcium_NA CalciumHigh CalciumLow ChangeBaseAlbumin ChangeBaseAlkPhosph ChangeBaseALT ChangeBaseBUN ChangeBaseCalcium ChangeBaseChloride ChangeBaseGlucose ChangeBasePotassium ChangeBaseSodium ChangeBaseTotBilirubin ChangeBaseTotProtein Chloride Chloride_NA ChlorideHigh ChlorideLow Creatinine Creatinine_NA Creatinine_NORM1 Creatinine_NORM2 Creatinine_NORM3 Creatinine_NORM4 CreatinineHigh CreatinineLow Glucose Glucose_NA GlucoseHigh GlucoseLow LDH LDH_NORM1 LDH_NORM4 LDHLow METHB_LLOD PChangeBaseA_Phyper Potassium Potassium_NA PotassiumHigh PotassiumLow ShiftAlbumin ShiftAlkPhosph ShiftALT ShiftBUN ShiftCalcium ShiftChloride ShiftCreatinine ShiftGlucose ShiftPotassium ShiftSodium ShiftTotBilirubin ShiftTotProtein Sodium Sodium_NA SodiumHigh SodiumLow TotBilirubin TotBilirubin_NA TotBilirubinHigh TotBilirubinLow TotProtein TotProtein_NA TotProteinHigh TotProteinLow WorstAlbumin_NA WorstAlkPhosph_NA WorstALT_NA WorstBUN_NA WorstCalcium_NA WorstChloride_NA WorstCreatinine_NA WorstGlucose_NA WorstPercRetic_NA WorstPotassium_NA WorstSodium_NA WorstTotBilirubin_NA WorstTotProtein_NA
Enzyme	BASEC_LDH BaseLDH BaseLDH_NA C_LDH ChangeBaseLDH CHBASEC_LDH ChBaseTaurine LDH_NORM2 LDH_NORM3 PCHBASEC_LDH ShiftLDH WorstLDH_NA
General	Chem_time Chemlab_Day Hema_Lab_day Hema_time
Hemoglobin Electrophoresis
Iron

Cardiovascular (0)

Genitourinary (6)

Data Element	Variables
Genitourinary Test
Urine Test	URIN_MCRORBC URIN_PH URIN_PROT URIN_SPGRA URIN_WBC Urinalysis_Day

Immune (0)

Microbiology Culture (0)

Musculoskeletal (0)

Neurologic (0)

Ocular (1)

Data Element	Variables
Eye exam	IHX_VISION

Other (0)

Physical Exam (0)

Reproductive (0)

Respiratory (0)

Therapeutics (29)

Medication (10)

Data Element	Variables
Antibiotics
Asthma
Blood Medication History
Cardiovascular
Compliance
Current Medication	CMED_Start_Day CMED_Stop_Day Drug_Class Drug_Name IHX_NEWMEDS Indication Ongoing Preferred_Term
Depression Medication History
Hydroxyurea
Medication
Neurologic Medication History
Pain
SCD Medication	DESFRD_1 DESFRYN
Sildenafil
Supplements

Surgery (0)

Transfusion (5)

Data Element	Variables
Blood Transfusion	Days_to_Tran1 TE_TranTOT TE_TranYN TRANSFUSED TRANSYN
Chronic Transfusion
Transfusion Complications

Transplantation (0)

Treatment (14)

Data Element	Variables
Discontinuation	DISC_ALLERGY DISC_FOCNEUR DISC_HEADACH DISC_HGBDRP DISC_HYPDYS DISC_METH DISC_PREG DISC_PRIAP DISC_PULMFAL DISC_RENDYS DISC_RETIN Discont_Form_day Discontin_Reason Discontinued
Oxygen
Treatment

Study Publications

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Functional Exercise Capacity (0)

Mental Health (0)

Neurodevelopment (0)

Neuropsychological (0)

Pain (0)

Physical Exam (0)

Psychosocial (0)

Quality of Care (0)

Quality of Life (0)

Sleep (0)

Technology Support (0)

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