Table 1. Published human studies of l... | American Society of Hematology

Table 1.

Published human studies of l-glutamine for SCA

Reference	clinicaltrials.gov registration	Study design	Genotype	Age, y	N	l-Glutamine regimen	Duration of therapy, wk	Primary outcome
11	N/A	Open-label, uncontrolled*	SS	>18	7	30 g/d	4	Laboratory
13	NCT00131508	Open-label, uncontrolled*	SS	5-18	27	0.3 g/kg bid	24	REE
12	N/A	Open-label, uncontrolled*	SS	≥18	11	30 g/d	4-8	Laboratory
14	NCT00125788	Phase 2, randomized, double-blind, placebo-controlled	SS or Sβ⁰	≥5	81	0.3 g/kg bid	48	Number of painful events at week 48
15,,-18	NCT01179217	Phase 3, randomized, double-blind, placebo-controlled	SS or Sβ⁰	≥5	230	0.3 g/kg bid	48	Number of “sickle cell crises”† at week 48

Reference	clinicaltrials.gov registration	Study design	Genotype	Age, y	N	l-Glutamine regimen	Duration of therapy, wk	Primary outcome
11	N/A	Open-label, uncontrolled*	SS	>18	7	30 g/d	4	Laboratory
13	NCT00131508	Open-label, uncontrolled*	SS	5-18	27	0.3 g/kg bid	24	REE
12	N/A	Open-label, uncontrolled*	SS	≥18	11	30 g/d	4-8	Laboratory
14	NCT00125788	Phase 2, randomized, double-blind, placebo-controlled	SS or Sβ⁰	≥5	81	0.3 g/kg bid	48	Number of painful events at week 48
15,,-18	NCT01179217	Phase 3, randomized, double-blind, placebo-controlled	SS or Sβ⁰	≥5	230	0.3 g/kg bid	48	Number of “sickle cell crises”† at week 48

Two other trials of l-glutamine for SCA are registered on clinicaltrials.gov, but the results are not posted, and no corresponding manuscripts have been published: NCT00586209 (study completed November 2009) and NCT01048905 (study completed March 2014).

bid, twice daily; N/A, not available; SS, homozygous SCA; Sβ⁰, sickle-β⁰-thalassemia.

No active or placebo control.

†

Includes painful events, acute chest syndrome, acute splenic sequestration, and priapism.

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