TerminatedNCT00532883Updated Jan 18, 2013Results posted

Hydroxyurea and Magnesium Pidolate to Treat People With Hemoglobin Sickle Cell Disease

A Phase 2 interventional study of Hydroxyurea and Magnesium Pidolate in Hemoglobin SC Disease, sponsored by St. Jude Children's Research Hospital. Terminated at 19 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2013-01-18.

Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Treatment

Why this study was terminated

Enrollment has been terminated due to a slow rate of enrollment.

Phase: Phase 2
Study type: Interventional
Enrollment: 44
Allocation: Randomized
Ages: 5 Years and older
Sex: All

Study summary

Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is characterized by dense red blood cells. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of pain episodes in people with HbSC.

Read the detailed description

SCD is an inherited blood disorder. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." SCD is caused by an abnormal type of hemoglobin, which is a protein inside red blood cells that carries oxygen. HbSC is a form of SCD that is characterized by the presence of dense red blood cells. People with HbSC usually develop less severe SCD symptoms than people with the more common form of the disease. There are limited treatment approaches aimed specifically at modifying the abnormal state of red blood cells. Also, few combination therapy treatments have been studied. The medication hydroxyurea is currently used to prevent sickle cell crises and to decrease the need for blood transfusions. The dietary supplement magnesium has not been widely studied as a treatment for SCD, but it may prevent dehydration, which may decrease the frequency of sickle cell crises. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of sickle cell crises in people with HbSC.

This 1-year study will enroll people with HbSC. Participants will be randomly assigned to one of the following four treatment groups:

Group 1 participants will receive placebo pills and placebo liquid.
Group 2 participants will receive hydroxyurea pills and placebo liquid.
Group 3 participants will receive placebo pills and magnesium pidolate liquid.
Group 4 participants will receive hydroxyurea pills and magnesium pidolate liquid.

Participants will receive the hydroxyurea or placebo pills once a day and the magnesium pidolate or placebo liquid twice a day for 11 months. Study visits will occur every 2 weeks during the first 2 months of the study, once a month for the following 9 months, and then at Year 1. At each visit, a physical exam and blood collection will occur. Selected visits will also include urine collection and a pregnancy test for female participants. Throughout the study, participants will record their study medication use in a daily diary.

Conditions studied

Hemoglobin SC Disease

Browse trials for

Hemoglobin SC Disease 29

Keywords

Sickle Cell Disease
Vaso-occlusive Event
Painful Crises
Acute Chest Syndrome

In context

Hemoglobin SC Disease

29 studies on the registry are indexed under Hemoglobin SC Disease; 2 are open to participants now.

This study's enrollment of 44 is above the median of 36 across 23 interventional studies indexed under Hemoglobin SC Disease.

Browse Hemoglobin SC Disease studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 5 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnosis of HbSC disease
Hemoglobin level between 8 and 12.5 g/dL
At least one vaso-occlusive event (e.g., pain, acute chest syndrome) in the 12 months prior to study entry. An episode of pain is defined as the occurrence of pain in the extremities, back, abdomen, chest, or head that lasts at least 2 hours; requires a visit to a hospital, emergency room, clinic, or provider's office; and is not explained except by SCD. Acute chest syndrome is defined as a new pulmonary infiltrate on a chest x-ray associated with a fever (greater than 38.5° C), tachypnea, wheezing, cough, or chest pain.
Regular compliance with comprehensive care
In a steady disease state and not experiencing an acute complication of SCD (i.e., no hospitalization, pain event, or episode of acute chest syndrome within the 1 month prior to study entry)

Exclusion criteria

Exclusion Criteria:

Previous transfusion with remaining hemoglobin A greater than 10%
Previous treatment with hydroxyurea within the last 3 months
Previous treatment with magnesium within the 3 months prior to study entry (including vitamins containing magnesium)
Poor compliance with previous treatment regimens
Liver dysfunction (SGPT greater than twice the upper limit of normal) within the 1 month prior to study entry
Kidney dysfunction (creatinine greater than or equal to 1.0 mg/dL for participants less than 18 years of age; greater than or equal to 1.2 mg/dL for participants 18 years of age or older) within the 1 month prior to study entry
Pregnant
Ten or more hospital admissions for pain in the 12 months prior to study entry
Daily use of narcotics
Treatment with any investigational drug in the 3 months prior to study entry
Less than 3% red blood cells with density greater than 41 g/dL (as measured by the ADVIA 120 system)
Positive HIV test
Other long-term illness or disorder other than SCD that could adversely affect performance in the study (e.g., tuberculosis)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 44 participants (actual)

Study arms

Placebo comparator
Placebo Pills and Placebo Liquid
Other: Placebo Pills and Placebo Liquid
Active comparator
Hydroxyurea Pills and Placebo Liquid
Drug: Hydroxyurea
Active comparator
Placebo Pills and Magnesium Pidolate Liquid
Drug: Magnesium Pidolate
Active comparator
Hydroxyurea Pills and Magnesium Pidolate Liquid
Drug: Hydroxyurea · Drug: Magnesium Pidolate

Interventions

DrugHydroxyurea
HU capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)
DrugMagnesium Pidolate
HU/Placebo capsules (20 mg/kg/day for 11 months) Mg liquid (0.6 mEq/kg/day for 11 months)
OtherPlacebo Pills and Placebo Liquid
HU/Placebo capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)

What researchers measure

Primary outcomes

Distribution of the Density of Hemoglobin SC Red Cells
An individuals' percentage of red blood cells with density greater than 41 g/dL as measured by Advia.
Time frame: measured 2 months after initiation of treatment

Results

Posted May 11, 2010

Limitations and caveats

This study was stopped early due to slow enrollment. It should therefore be viewed as a pilot study.

Participant flow

Subjects were recruited from October 2006 through June 2008 at 10 sites across the United States. Subjects were recruited from sickle cell specific clinics.

Participant flow — Overall Study
Milestone	Hydroxyurea/Magnesium	Hydroxyurea/Mg Placebo	HU Placebo/Magnesium	HU Placebo/Mg Placebo
Started	11	12	10	11
Completed	5	5	6	6
Not completed	6	7	4	5
Withdrew: Adverse event	1	0	0	1
Withdrew: Lost to follow-up	1	1	1	0
Withdrew: Withdrawal by subject	0	1	1	0
Withdrew: Subject was nonadherent	0	1	1	0
Withdrew: Early study termination	4	4	1	4

Outcome measures

PrimaryDistribution of the Density of Hemoglobin SC Red Cells

An individuals' percentage of red blood cells with density greater than 41 g/dL as measured by Advia.

Time frame:: measured 2 months after initiation of treatment
Reported as:: Mean · percent of cells

Distribution of the Density of Hemoglobin SC Red Cells
percent of cells	Hydroxyurea/Magnesium	Hydroxyurea/Mg Placebo	HU Placebo/Magnesium	HU Placebo/Mg Placebo
Distribution of the Density of Hemoglobin SC Red Cells	12.09 ± 5.075	11.16 ± 7.296	10.49 ± 4.572	12.79 ± 3.739

Statistical analysis

Hydroxyurea/Magnesium vs Hydroxyurea/Mg Placebo vs HU Placebo/Magnesium vs HU Placebo/Mg Placebo · Mixed Models Analysis · p = 0.93 (This is a global test comparing all four treatment arms.)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Hydroxyurea/Magnesium Pidolate	—	3/11 (27.3%)	9/11 (81.8%)
Hydroxyurea/Placebo	—	2/12 (16.7%)	10/12 (83.3%)
Placebo/Magnesium Pidolate	—	3/10 (30%)	9/10 (90%)
Placebo/Placebo	—	2/11 (18.2%)	10/11 (90.9%)

Most frequent serious events

Most frequent serious events
Event	Hydroxyurea/Magnesium Pidolate	Hydroxyurea/Placebo	Placebo/Magnesium Pidolate	Placebo/Placebo
Sickle cell anaemia with crisisCongenital, familial and genetic disorders	3/11	1/12	3/10	2/11
Pharyngitis streptococcalInfections and infestations	1/11	0/12	0/10	0/11
Acute chest syndromeBlood and lymphatic system disorders	0/11	1/12	0/10	0/11
AnaemiaBlood and lymphatic system disorders	0/11	1/12	0/10	0/11
CellulitisInfections and infestations	0/11	1/12	0/10	0/11
PneumoniaInfections and infestations	0/11	1/12	0/10	0/11
PyrexiaGeneral disorders	0/11	1/12	0/10	0/11
Skin graftSurgical and medical procedures	0/11	1/12	0/10	0/11

Most frequent other events

Showing 10 of 80

Most frequent other events
Event	Hydroxyurea/Magnesium Pidolate	Hydroxyurea/Placebo	Placebo/Magnesium Pidolate	Placebo/Placebo
Sickle cell anaemia with crisisCongenital, familial and genetic disorders	6/11	6/12	4/10	8/11
HeadacheNervous system disorders	3/11	5/12	1/10	3/11
VomitingGastrointestinal disorders	1/11	1/12	3/10	3/11
ConstipationGastrointestinal disorders	0/11	1/12	2/10	1/11
Nasal congestionRespiratory, thoracic and mediastinal disorders	0/11	0/12	2/10	1/11
RashSkin and subcutaneous tissue disorders	2/11	0/12	2/10	0/11
Abdominal painGastrointestinal disorders	2/11	1/12	0/10	2/11
Back painMusculoskeletal and connective tissue disorders	2/11	0/12	0/10	0/11
CoughRespiratory, thoracic and mediastinal disorders	1/11	0/12	1/10	2/11
DiarrhoeaGastrointestinal disorders	2/11	2/12	1/10	2/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Hydroxyurea/Magnesium	Hydroxyurea/Mg Placebo	HU Placebo/Magnesium	HU Placebo/Mg Placebo	Total
<=18 years	10	9	9	9	37
Between 18 and 65 years	1	3	1	2	7
>=65 years	0	0	0	0	0

Age Continuous
Age Continuous(years)	Hydroxyurea/Magnesium	Hydroxyurea/Mg Placebo	HU Placebo/Magnesium	HU Placebo/Mg Placebo	Total
Mean	12.5 ± 4.41	16.8 ± 12.6	14.8 ± 8.45	17.3 ± 12.41	16.7 ± 9.81

Sex: Female, Male
Sex: Female, Male(Participants)	Hydroxyurea/Magnesium	Hydroxyurea/Mg Placebo	HU Placebo/Magnesium	HU Placebo/Mg Placebo	Total
Female	4	8	3	4	19
Male	7	4	7	7	25

Region of Enrollment
Region of Enrollment(participants)	Hydroxyurea/Magnesium	Hydroxyurea/Mg Placebo	HU Placebo/Magnesium	HU Placebo/Mg Placebo	Total
United States	11	12	10	11	44

Study locations

19 sites

University of Alabama at Birmingham
Birmingham, Alabama 35233, United States
Children's Hospital and Research Center
Oakland, California 94609-1809, United States
University of California Davis
Sacramento, California 95817, United States
University of Colorado
Aurora, Colorado 80045, United States
University of Miami
Miami, Florida 33136, United States
Children's Healthcare of Atlanta
Atlanta, Georgia 30342-1600, United States
University of Louisville
Louisville, Kentucky 40202, United States
Johns Hopkins University
Baltimore, Maryland 21205, United States
Boston Medical Center
Boston, Massachusetts 02118, United States
Children's Hospital Boston
Boston, Massachusetts 02118, United States
University of Mississippi Medical Center
Jackson, Mississippi 39216, United States
Montefiore Medical Center
Bronx, New York 10463, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
Cincinnati Children's Hospital
Cincinnati, Ohio 45229, United States
University of Oklahoma
Oklahoma City, Oklahoma 73104, United States
Saint Christopher's Hospital
Philadelphia, Pennsylvania 19134-1095, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19444, United States
St. Jude Children's Research Hospital
Memphis, Tennessee 38105, United States
Children's Medical Center
Dallas, Texas 75235, United States

References and documents

Publications

Wang W, Brugnara C, Snyder C, Wynn L, Rogers Z, Kalinyak K, Brown C, Qureshi A, Bigelow C, Neumayr L, Smith-Whitley K, Chui DH, Delahunty M, Woolson R, Steinberg M, Telen M, Kesler K. The effects of hydroxycarbamide and magnesium on haemoglobin SC disease: results of the multi-centre CHAMPS trial. Br J Haematol. 2011 Mar;152(6):771-6. doi: 10.1111/j.1365-2141.2010.08523.x. Epub 2011 Jan 31. PubMed 21275961 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00532883
Lead sponsor: St. Jude Children's Research Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Responsible party: Sponsor
First posted: Sep 21, 2007
Start date: Jan 2007
Primary completion: Mar 2009
Completion: Aug 2009
Results posted: May 11, 2010
Last update: Jan 18, 2013

Study contacts

Winfred C. Wang, MD

principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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