A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia

Conditions

• Sickle Cell Anemia
• Sickle ß0-Thalassemia

Eligibility Criteria

Sex

ALL

Age

5 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• L-glutamine — DRUG
  0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended.
• Placebo — DRUG
  0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration.

Study Details

The purpose of this research is to evaluate the effects of L-glutamine as a therapy for Sickle Cell Anemia or Sickle ß0 Thalassemia as evaluated by the number of occurrences of sickle cell crises.

Key Dates

Start date

May 31, 2010

Status verified

Jul 2017

Primary completion

Mar 31, 2014

Completion

Mar 31, 2014

Study Design

Enrollment

230 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: L-glutamine
  Patients will be randomized to receive investigational product, L-Glutamine.
• Placebo Comparator: 100% maltodextrin
  Patients will be randomized to receive Placebo.

Primary Outcome Measure

The Number of Occurrences of Sickle Cell Crises [ Time Frame: 48 weeks ]

Locations (31)

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