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NCT ID: NCT01125618 Completed - Child Survival Clinical Trials

Millennium Villages Project in Sub-Saharan Africa

MVP
Start date: January 2005
Phase: N/A
Study type: Interventional

The Millennium Villages Project involves the coordinated and simultaneous delivery of a package of proven interventions in health, agriculture, infrastructure and education. The project works in partnership with governments in 10 African countries in areas where progress towards achieving the Millennium Development Goals has been insufficient. The Project evaluation will test the following hypotheses: 1. That after 5 years of operation, villages exposed to the MVP intervention will have a lower rate of under-5 mortality and parallel gains in MDG-related secondary outcomes when compared to similar villages not receiving the intervention. 2. That the coordinated delivery a multi-sector package of health and development interventions implemented through a broad-based local partnership is feasible in a diversity of sub-Saharan African contexts, and; 3. The intervention package can be delivered at a scalable cost of $40 per person per year in the health sector and $110 per person per year in total

NCT ID: NCT01111864 Completed - Clinical trials for Bacterial Infections

Changes in Microbiota and Iron Status After Iron Fortification of Complementary Foods

Start date: February 2010
Phase: N/A
Study type: Interventional

Infants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods using micronutrient powders can be an effective approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient powders that contain the entire iron RDA for a child in a single dose in areas with high rates of infections from malaria and diarrheal disease. Therefore, in this study, we will investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of highly bioavailable iron, provided by a micronutrient powder added to a complementary food. The study aim is to determine if in-home fortification using an iron-containing micronutrient powder in Kenyan infants will improve iron status and/or modify the composition and metabolic activity of the gut microbiota. Active surveillance will be done weekly to monitor the health of the infants. Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding trial in which 330 infants will be randomized to receive a micronutrient powder containing either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and after 6 months will be used to define the iron status and the anemia level of the infants. Stool samples (2 at baseline before intervention, 6 throughout the study and additional samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the entire study (n=330), we will measure changes in iron status over 1 year.

NCT ID: NCT01103713 Terminated - Clinical trials for Asymptomatic Parasitemia In Pregnancy

Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The study will be conducted in asymptomatic pregnant women with P. falciparum parasitemia. The subjects will be given 3 day dosing regiment of the fixed-dose combination of Azithromycin and Chloroquine. Parasitological clearance rate with polymerase chain reaction data will be evaluated on Day 28 as primary endpoint.

NCT ID: NCT01103063 Terminated - Clinical trials for Intermittent Preventive Treatment In Pregnancy (IPTp)

Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

Start date: October 2010
Phase: Phase 3
Study type: Interventional

The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.

NCT ID: NCT01088958 Completed - Clinical trials for Anemia, Iron-deficiency

Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya

NICHE
Start date: January 2007
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate the effectiveness of household-based distribution of evidence-based health products and to measure the health impact of these combined interventions on a population basis.

NCT ID: NCT01084096 Completed - Preterm Birth Clinical Trials

Trial of the Use of Antenatal Corticosteroids in Developing Countries

ACT
Start date: October 2011
Phase: Phase 3
Study type: Interventional

Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.

NCT ID: NCT01073488 Completed - Clinical trials for Maternal Morbidity and Mortality

Emergency Obstetric and Neonatal Care: The EmONC Trial

EmONC
Start date: December 2008
Phase: N/A
Study type: Interventional

The objective of this cluster randomized controlled trial is to reduce maternal and neonatal mortality by increasing access to and improving the quality of obstetric and neonatal care for pregnant women in study clusters. It is hypothesized that a 25% reduction in >28 week or >1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be introduced by an EmONC team.

NCT ID: NCT01071174 Completed - HIV Infections Clinical Trials

A Safety Study of Dapivirine Vaginal Ring in Africa

Start date: April 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.

NCT ID: NCT01067443 Completed - Clinical trials for Primary Visceral Leishmaniasis

Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa

Start date: March 2010
Phase: Phase 2
Study type: Interventional

This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.

NCT ID: NCT01058694 Completed - HIV Infections Clinical Trials

The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya

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

The purpose of proposed research is to implement a randomized study that will allow us to understand and address a number of key barriers to patient adherence as well as study the effects of better adherence on health and socio-economic outcomes.