Clinical Trials Logo
  1. Home
  2. Anemia
  3. NCT00497471
  4. Details
NCT00497471 Clinical Trial

RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants

Anemia Clinical Trial

Official title:
The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00497471
Other study ID # IronMal
Secondary ID
Status Terminated
Phase N/A
First received July 5, 2007
Last updated July 5, 2007
Start date February 1995
Est. completion date July 1999

Study information
Verified date July 2007
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Tanzania: National Institute for Medical Research
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission

Description:

411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprim™ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.

Recruitment information / eligibility
Status Terminated
Enrollment 832
Est. completion date July 1999
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 1 Day
Eligibility Inclusion Criteria:

- Born in San Francis Designated District Hospital of Ifakara

Exclusion Criteria:

- Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus

- Twins

- Birth weight < 1,5 kg

- Clinical signs of cerebral asphyxia

- Clinical signs of neonatal or congenital infection

- Mother unreliable (deaf, mentally handicapped)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)

• iron (2 mg/kg/daily)

Locations
Country Name City State
Tanzania Ifakara Centre Ifakara

Sponsors (3)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona Agencia Española de Cooperación Internacional, World Health Organization

Country where clinical trial is conducted

Tanzania, 

References & Publications (1)

Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemopro — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Malaria During first year of life
Primary Severe Anemia (PCV < 25%) During first year of life
Secondary Clinical Malaria After first year of life
Secondary Severe Anemia (PCV < 25%) After first year of life
Secondary Outpatient visits
Secondary Hospital Admissions
Secondary Severe malaria
See also
  Status Clinical Trial Phase
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03341338 - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed NCT00060398 - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Phase 3
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Not yet recruiting NCT06309641 - Methemoglobinemia Following Intravenous Iron Treatment
Completed NCT02912533 - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02912494 - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT03822884 - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers Phase 1
Completed NCT02930850 - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation N/A
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
Completed NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Withdrawn NCT01934842 - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate N/A
Completed NCT01922479 - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure Phase 4
Completed NCT02310113 - Transfusion and Skeletal Muscle Tissue Oxygenation N/A
Completed NCT01693029 - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa Phase 3
Completed NCT01458028 - Age and Gender Effects on the Pharmacokinetics of BAY85-3934 Phase 1
Completed NCT01432717 - Study of ACE-536 in Healthy Postmenopausal Women Phase 1