Chloroquine and Post Malaria Anaemia Study (CQ-PMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00473837
Recruitment Status : Completed
First Posted : May 16, 2007
Results First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Information provided by (Responsible Party):
Medical Research Council Unit, The Gambia

Brief Summary:
The pathogenesis of post-malaria anaemia is multifactorial. Iron supplementation remains the mainstay of management of moderate and severe anaemia; however the management of mild anaemia (Hb 80-110g/l) is problematic as population supplementation studies of children in malaria endemic areas demonstrate adverse effects in children with mild anaemia. We hypothesize that the anti-inflammatory, anti-malarial and anti-macrophageal iron loading effects of chloroquine could make it a useful drug in the management of mild post malaria anaemia. To test this hypothesis, we plan to randomize children (aged 12 months to 6 years) with post malaria anaemia (Hb 70-110g/l) to receive a standard anti-malarial treatment, co-artemether . All children with parasitologic cure after three days on treatment will be randomised to receive either weekly chloroquine or weekly placebo starting from day 10 till day 90. By comparing the curve of haemoglobin change between day 3 and day 30 in the placebo arms of the two groups, we will test the effect of chloroquine vs. ACT treatment on macrophageal iron loading and release in acute clinical malaria. By comparing the haemoglobin change between day 3 and day 90 between the weekly chloroquine arms and the weekly placebo arms we will test the longer-term anti-inflammatory and anti- malarial effects of weekly chloroquine prophylaxis. In addition to the primary endpoint, we plan to assess potential mechanisms of action by determining parasite clearance, peripheral cytokine production and iron flux

Condition or disease Intervention/treatment Phase
Malaria Anaemia Drug: Chloroquine Drug: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chloroquine as a Therapeutic Option for Mild Post Malaria Anaemia
Study Start Date : July 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: Treatment
Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90
Drug: Chloroquine
This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days
Placebo Comparator: Control
Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90
Drug: Placebo
The placebo is an orange syrup in a 60ml amber coloured glass bottle containing sucrose syrup base. The syrup was prepared by the Pharmacy department of the Royal Victorial Teaching Hospital and Atlantic Pharmaceuticals Limited, Banjul

Primary Outcome Measures :
  1. Changes in Haemoglobin Concentration From Day 3 Post Treatment of Malaria Episode to Day 90 in the Weekly Chloroquine and Placebo Arms [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Curve of Hb Change Between Day 3 and Day 30 in the Two Placebo Arms; Changes in Markers of Iron Status, Measures of Inflammation, and Hb Response Between Day 3 and Day 30, and Between Day 3 and Day 90 [ Time Frame: 90 days ]

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Ages Eligible for Study:   12 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

All children aged 12 months to 6 years in the 13 study villages will be enrolled in the study and followed up for the duration of the study. The inclusion criteria for randomization will be:

  1. Children aged 12 months to 6 years; and
  2. History of fever in the preceding 48 hours or a measured temperature > 37.5oC plus asexual forms of P. falciparum in the peripheral blood film of 500/μl or above; and
  3. Hb <110g/l and >69g/l (Our choice of the upper limit of moderate anaemia (70 - 79g/l) is to enable us assess the response to our interventions of severer forms of anaemia while at the same time reducing the risk of adverse events which might occur with lower levels of Hb).

Exclusion Criteria:

  1. Refusal of parent or guardian to give consent to the child's participation in the study
  2. Inability of the subjects to take oral medications
  3. Presence of features of severe malaria as defined by WHO50, with the exception of anaemia and parasite density
  4. Children who have urgent need for blood transfusion as indicated by the presence of tachypnoea, tachycardia & gallop rhythm, tender hepatomegaly
  5. Children with known haemoglobinopathy
  6. Children with a weight for height Z score below -3SD of WHO/NCHS standard
  7. Enrolment in another research project

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00473837

Sponsors and Collaborators
Medical Research Council Unit, The Gambia
Principal Investigator: Chidi V Nweneka, MSc. Medical Research Council Unit, The Gambia
Study Director: Sophie Moore, PhD Medical Research Council Unit, The Gambia

Additional Information:
1. Weatherall DJ, et al. Br Med Bull 1982;38(2):147-51. 2. Schwartz RS, et al.Blood 1987;69(2):401-7. 4. Looareesuwan S, et al. Acta Trop 1991;48(4):263-70. 5. Abdalla SH, et al. Clin Lab Haematol 1988;10(1):33-40. 6. Jootar S, et al. Clin Lab Haematol 1993;15(2):87-92. 7. Jason J, et al. Clin Immunol 2001;100(2):208-18. 8. Clark IA, et al. Br J Haematol 1988;70(1):99-103. 9. Biemba G, et al. Trop Med Int Health 2000;5(4):256-62. 10. Othoro C, et al, J Infect Dis 1999;179(1):279-82. 11. Luty AJ, et al. Infect Immun 2000;68(7):3909-15. 12. Camacho LH, et al. Ann Trop Med Parasitol 1998;92(5):525-37. 13. Kwiatkowski D, et al. Clin Exp Immunol 1989;77(3):361-6. 15. Wenisch C, et al. Clin Immunol Immunopathol 1995;74(1):115-7. 17. Helleberg M, et al. Malar J 2005;4(1):56. 18. Knutson M, et al, Crit Rev Biochem Mol Biol 2003;38(1):61-88. 23. Abdalla S, et al. Br J Haematol 1980;46(2):171-83. 24. Bojang KA, et al. Trans R Soc Trop Med Hyg 1997;91(5):557-61. 30. Moore HP, et al. Nature 1983;302(5907):434-6. 31. Agarwal SL, et al, Arch Int Pharmacodyn Ther 1963;143:401-7. 32. Ayitey-Smith E, et al. J Pharm Pharmacol 1974;26(3):208-9. 33. Moss RB. Chest 1995;107(3):817-25. 34. Lancz GJ, et al. Proc Soc Exp Biol Med 1971;136(4):1289-93. 35. Tsai WP, et al. AIDS Res Hum Retroviruses 1990;6(4):481-9. 36. Boelaert JR, et al. J Acquir Immune Defic Syndr 2001;26(3):300-1. 37. Neale ML, et al.Immunology 1988;64(1):81-5. 39. Cash JM, et al. N Engl J Med 1994;330(19):1368-75. 40. Legssyer R, et al. Biochem Pharmacol 1999;57(8):907-11. 41. Salihu HM, et al. Trop Med Int Health 2002;7(1):29-34. 42. Cot M, le Hesran JY, et al. Ann Trop Med Parasitol 1998;92(1):37-43.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medical Research Council Unit, The Gambia Identifier: NCT00473837     History of Changes
Other Study ID Numbers: SCC1076
First Posted: May 16, 2007    Key Record Dates
Results First Posted: October 13, 2014
Last Update Posted: October 13, 2014
Last Verified: October 2014

Keywords provided by Medical Research Council Unit, The Gambia:
iron delocalisation

Additional relevant MeSH terms:
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Chloroquine diphosphate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antinematodal Agents