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Anaemia clinical trials

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NCT ID: NCT00494416 Completed - Anaemia Clinical Trials

Different Approaches for Delivery of IPT in Pregnancy in Burkina Faso

Start date: June 2007
Phase: N/A
Study type: Interventional

IPT/SP was adopted in 2005 by The Ministry of Health (MoH) of Burkina Faso to replace chemoprophylaxis with CQ in pregnancy. The new strategy is being implemented but no delivery approach was defined and presumably IPT/SP will only be delivered to pregnant women presenting at ANC visits. It would be of extreme importance to ensure a better coverage and higher compliance to make the new strategy effective. In order to obtain a more efficient IPT/SP programme with a good level of compliance and coverage, several delivery approaches beside ANC should be explored. The study site will be in Pissy health district covering both peri-urban Ouagadougou city and rural areas. Participants include pregnant women irrespective of gravidity residing in the study area. The study is a prospective comparative study of 3 different approaches of delivering IPT/SP in the catchment areas of rural health facilities. The approaches will be the following: 1. Passive health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visits. 2. Joint, with an advanced strategies delivery approach (JAS). In addition to passive delivery at health centres, the pregnant women will be reached during preventive activities the health staff carry out regularly in villages, such as immunization, health promotion, and even ANC visits. 3. Community based distribution delivery approach (CBD). In addition to passive delivery at health centres, the pregnant women will be reached by traditional birth attendants (TBAs) or representatives of village women's associations (RWAs). Each approach will be implemented in a zone constituted by the catchment area of a number of health centres to achieve the required sample size. The zones will be randomly assigned to a delivery approach. The main outcomes to be measured are: a) the coverage of IPT, b) compliance, c) infection prevalence, d) Hb level, e) difficulties and constraints of each approach, f) the acceptability to population and health staff and g) the performance of each approach to deliver IPT /SP. to be able to identify a significant increase in coverage of 10%, each group should be composed of n = 3841 pregnant women. Cross sectional surveys will be carried out at the beginning, during and at the end of the study period. The study will be carried out over 24 months from June 2007.

NCT ID: NCT00463632 Completed - Pregnancy Clinical Trials

Schistosomiasis in Women of Reproductive Age in Burkina Faso: Implications for Control

Start date: January 2007
Phase: N/A
Study type: Observational

Cross-sectional study of prevalence and intensity of schistosome infection in pregnant women, follow-up into postpartum, and the association of schistosome infection with haemoglobin concentration, compared to a group of non-pregnant women.

NCT ID: NCT00463593 Completed - Anaemia Clinical Trials

Schistosomiasis in Formal and Non-Formal Schools in Uganda: Implications for Control Programmes

Start date: December 2006
Phase: N/A
Study type: Observational

Current efforts to control schistosomiasis and soil-transmitted helminthes infections focus on the school-age population, and school-based treatment delivery programs offer a major cost advantages because of the use of the existing school infrastructure and the fact that schoolchildren are accessible through schools. However, in many developing countries, large numbers of school-age children are not in school and this has raised questions about the effectiveness of school-based programs in reaching non-enrolled children. Increasingly, the non-formal education sector is providing a growing solution to the problem of poor enrolment in basic education, especially in sub-Saharan Africa, and has recently been used to deliver praziquantel as part of a national schistosomiasis control program in Uganda. However, it is unclear how effective this program has been in reaching children who attend non-formal schools and whether the program has been reaching children from the poorest households.

NCT ID: NCT00443170 Completed - Healthy Subjects Clinical Trials

A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects

Start date: November 2006
Phase: Phase 1
Study type: Interventional

This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.

NCT ID: NCT00439595 Completed - Anaemia Clinical Trials

A Trial of 2 'Point of Care' Diagnostic Methods to Improve Detection and Treatment of Anaemia in African Children

EARS
Start date: February 2007
Phase: N/A
Study type: Interventional

A high proportion of children under the age of 5 years and pregnant women in Tanzania is anaemic, particularly in areas of high malaria transmission. The symptoms of anaemia are often non-specific or absent and clinical judgement is generally insensitive in estimating Hb levels, especially in infants who are assessed by basic grade health staff. Thus while treatment for the common causes of anaemia is available, many cases are not treated due to difficulties in recognising anaemia. New diagnostic tools can increase the sensitivity of anaemia detection compared to clinical diagnosis but no studies have demonstrated their effectiveness in increasing case-detection and treatment of anaemic patients at the first level of healthcare. In addition, the costs of their use in relation to any increase in numbers of cases treated are not known and this knowledge is needed to guide public health decisions. Two methods of measuring anaemia are currently suitable for use at the first level of care; Copack Haemoglobin colour scale (HBCS) and Hemocue portable photometry. We propose to compare the effectiveness in basic health facilities of these 2 simple diagnostic tools compared to control dispensaries (current practice) in increasing rates of detection and treatment of anaemia in children under the age of 5 years and pregnant women over the course of 1 year in a cluster-randomised trial in 30 dispensaries in a malaria-endemic area of NE Tanzania.

NCT ID: NCT00432367 Completed - Pregnancy Clinical Trials

Intermittent Preventive Treatment (IPTp) Versus Rapid Diagnostic Testing (RDT) and Treatment of Malaria in Pregnancy

Start date: February 2007
Phase: Phase 3
Study type: Interventional

Among the best practices recommended for malaria control during pregnancy is ensuring effective case management of malaria illness. However, this is often not practiced because (1) malaria infection in pregnancy is often asymptomatic, (2) peripheral parasitaemia may be absent even when the placenta is heavily parasitized, (3) implementing diagnosis and treatment of malaria within a routine antenatal service may be difficult and (4) antimalarial treatment options available to pregnant women are limited due to resistance to chloroquine(CQ) and sulfadoxine-pyrimethamine(SP0 and paucity of safety and efficacy data on other antimalarial drugs in pregnancy, particularly artemisinin combination treatments (ACT). Therefore the commonest recommended practice in pregnancy is the administration of SP as intermittent preventive treatment (SP-IPTp). However, the effectiveness of SP-IPTp has been questioned because parasite resistance to SP is spreading rapidly across sub-Saharan Africa. This is a three-arm open label randomised control non-inferiority trial of insecticide-treated nets(ITN) plus rapid diagnostic test(RDT) screening, and treatment with SP or amodiaquine plus artimisinin(AQ+AS) versus ITN plus IPTp using SP. It is to be carried out in pregnant women of all parities presenting at enrolling antenatal clinics with a gestation of 16 to 20 weeks at their first booking. The key objectives are to demonstrate that (1) the prevalence of severe anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation (2) the prevalence of low birth weight (BW < 2500g) at delivery or within 72 hours after delivery (3) the prevalence of placenta parasitaemia and (4) the incidence of serious and non-serious adverse events in the ITN plus RDT screening and treatment arm are not greater than those in the ITN plus IPTp arm. Alongside the clinical assessments, health care cost assessments will be done to determine the cost-effectiveness of the two delivery strategies measured as cases of severe maternal anaemia averted.

NCT ID: NCT00414479 Completed - Malaria Clinical Trials

Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment

Start date: July 2006
Phase: N/A
Study type: Observational

The purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).

NCT ID: NCT00396435 Completed - Kidney Failure Clinical Trials

Correction of Anaemia and Progression of Renal Failure on Transplanted Patients

Start date: April 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate, on renal transplanted patients with CGD, the effect of two levels of haemoglobin on quality of life at 6 months and the speed of progression of renal function degradation at 24 months. This study will recruit 140 patients in 21 centers in France.

NCT ID: NCT00386074 Completed - Anaemia Clinical Trials

Iron-fortified Whole Maize Flour Trial

Start date: May 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess whether NaFeEDTA and electrolytic iron improve iron status of young school children, when added as iron fortificants in whole maize flour.

NCT ID: NCT00347113 Completed - Malaria Clinical Trials

Schistosome and Intestinal Worm Infections and Malaria Morbidity Among School and Pre-school Children in, Tanzania

Start date: July 2006
Phase: N/A
Study type: Interventional

The proposed study has as the main objective to investigate the effect of schistosome and STH infections and the effect of an anthelminthic intervention on P. falciparum malaria, related anaemia and malaria antibody responses among school and pre-school children in Mwanza, Tanzania. The study will include a cross-sectional baseline survey followed by an anthelminthic intervention trial of two years duration. At baseline, prevalence and intensity of malaria, schistosome and STH infections and the prevalence of anaemia will be determined by examination of blood, faecal and urine samples. Spleen and liver size and consistency will be determined by palpation. P. falciparum specific antibodies will be determined by ELISA. All children will be treated with a single dose of praziquantel 40mg/kg and albendazole 400mg. Children selected to participate in the intervention trial will be randomized into two groups, an intervention group of 258 children which will be followed up with albendazole 400mg and praziquantel 40mg/kg at three months interval and a control group of 258 children which will be followed up with praziquantel 40mg/kg and albendazole 400mg once a year in accordance with the National Schistosomiasis and Soil-transmitted Helminths Control Programme. At 12 months and 24 months follow-up, all examinations conducted at baseline survey will be repeated.