Anemia, Sickle Cell Clinical Trial
Official title:
A Randomized Controlled Trial of Oral Glutamine Supplementation Versus a Placebo Supplement in Children With Sickle Cell Anemia
Children with sickle cell anemia (SCA) seem to have higher energy needs than children who do
not have the disease. This may be the reason why children and teenagers with sickle cell
anemia tend to be smaller, weigh less, and have less fat and muscle than children and teens
that do not have the disease.
This study is being done to find out if giving a supplement called glutamine will help
children with sickle cell anemia by lowering their energy needs and improving their growth
and strength. Children will be randomly assigned (like a flip of a coin) to one of two
groups. One group will take glutamine and one group will take a placebo (a protein mixture
that looks like glutamine but may not have the same effect in the body). No one will know
which group is taking which supplement until the study has been completed. Children will be
in the study for 12 months.
1. The study will compare the effect of glutamine and placebo on resting energy
expenditure (REE) in children with sickle cell anemia (SCA) by comparing the change in
REE ratio between baseline and 12 months.
2. The study investigates the effect of oral glutamine and placebo on body composition in
children with SCA by comparing the difference in body mass indexes (BMIs) and percent
of body fat (DEXA Scan) between baseline and 12 months of treatment in the two groups.
3. This Study will investigate the effect of oral glutamine and placebo on growth in
children with SCA by comparing the Z scores for one year before baseline to 1 year
while on study.
4. This study will investigate the effect of oral glutamine and placebo in children with
SCA by comparing the difference in the levels of plasma and red blood cell glutamine
between baseline and 12 months of treatment in the two groups.
5. This study will investigate the clinical effects (strength and exercise endurance) of
oral glutamine and placebo in children with SCA by comparing the difference between
baseline and 12 months of treatment in the two groups.
6. This study will evaluate quality of life in children with SCA who have glutamine or
placebo for 12 months.
7. This study will evaluate the changes in REE over time in a small group of patients that
will have REE measurement at months 3, 6, and 9. This objective will be offered to all
patients, but will be "additional studies" that are not required to participate in the
protocol.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06078696 -
Siplizumab for Sickle Cell Disease Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT04134299 -
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
|
N/A | |
| Completed |
NCT02561312 -
Comparison of Two Methods of Transfusion for Stroke Prevention in Sickle Cell
|
||
| Completed |
NCT00890396 -
Long-Term Effects of Hydroxyurea in Children With Sickle Cell Anemia (The BABY HUG Follow-up Study)
|
||
| Completed |
NCT00059293 -
Transcranial Doppler (TCD) Ultrasound of Subjects Enrolled in BABY HUG - Ancillary to BABY HUG
|
||
| Terminated |
NCT00034528 -
Stem Cell Transplantation After Reduced-Dose Chemotherapy for Patients With Sickle Cell Disease or Thalassemia
|
Phase 2 | |
| Completed |
NCT00005277 -
Cooperative Study of The Clinical Course of Sickle Cell Disease
|
N/A | |
| Active, not recruiting |
NCT04170348 -
Daily Vitamin D for Sickle-cell Respiratory Complications
|
Phase 2 | |
| Completed |
NCT04584528 -
Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
|
N/A | |
| Recruiting |
NCT02286154 -
Therapeutic Response Evaluation and Adherence Trial (TREAT)
|
N/A | |
| Completed |
NCT02857023 -
Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
|
N/A | |
| Withdrawn |
NCT01925001 -
Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis
|
Phase 2 | |
| Terminated |
NCT00122980 -
Stroke With Transfusions Changing to Hydroxyurea
|
Phase 3 | |
| Completed |
NCT00246077 -
Quality of Life of Children With Sickle Cell Disease Who Are Getting Chronic Transfusions With a Lifeport
|
N/A | |
| Completed |
NCT00094887 -
Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises
|
Phase 2 | |
| Completed |
NCT00035763 -
Pain in Sickle Cell Epidemiologic Study
|
N/A | |
| Terminated |
NCT04091737 -
CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease
|
Phase 1 | |
| Completed |
NCT00005300 -
Investigation of Selected Patient Groups From The Cooperative Study of Sickle Cell Disease
|
N/A | |
| Recruiting |
NCT04351698 -
SMILES: Study of Montelukast in Sickle Cell Disease
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT06290401 -
A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
|
Phase 2 |