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NCT ID: NCT03372772 Recruiting - Patient Compliance Clinical Trials

Effect of Levocarnitine Supplementation for the Management of Fatigue in Levothyroxine-Treated Hypothyroid Patients

Start date: March 16, 2017
Phase: N/A
Study type: Interventional

It has been observed that despite administration of apparently adequate thyroid hormone replacement in hypothyroid patients, many of them experience persistent fatigue and fatigue-related symptoms. Carnitine transports long chain fatty acids into the mitochondria whereupon the high energy source (ATP) becomes synthesized. Levocarnitine administration reduced fatigue related symptoms in hypothyroid patients receiving thyroid hormone replacement. The present study deals with alleviation of fatigue in hypothyroid patients by carnitine supplimentation.

NCT ID: NCT03321591 Recruiting - Child Development Clinical Trials

Maternal Cognitive Function and Neurobehavioral Development of Underprivileged Children

Start date: September 12, 2017
Phase: N/A
Study type: Observational

It is estimated that over 200 million children under 5 years of age in developing countries are not attaining their developmental potential (e.g., neurobehavioral development) primarily because of poverty and associated health, nutritional deficiencies, and unstimulating home environment. Child's Neurobehavioral development consists of several interdependent domains of sensory-motor, cognitive-language, and social-emotional function. Experiences in the first few years of life are of particular importance because vital development occurs during this period. Early under nutrition, iron-deficiency, environmental toxins, stress, and poor stimulation and social interaction can affect brain structure and function. Stunting, inadequate cognitive stimulation, iodine deficiency, and iron deficiency anemia are identified as key risk factors, where the need for cognitive intervention is urgent, that prevent millions of young children from fulfilling their developmental potential and neurobehavioral development. It is clear that underprivileged children require not only good health, nutrition, and wealth but also supportive and caring environments and cognitive stimulation for their optimum neurobehavioral development as in the case of Bangladesh. Cognitive function and self-esteem of mothers is crucial for having the optimum outcome from intervention. However, little is known regarding the importance of mother's cognitive ability influencing different domains of her children's neurobehavioral development. This is how, the investigators plan to measure the maternal cognitive function and to assess the neurobehavioral development of underprivileged children. The investigators will enroll 200 mothers and children as a sample of the present study. Bayley Scales of Infant and Toddler Development will be used along with other interview scales.

NCT ID: NCT03305939 Recruiting - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Lifestyle Intervention IN Gestational Diabetes (LIVING)

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Burden: Diabetes mellitus is a major public health concern for both the developed and the developing countries. Globally 246 million people affected with diabetes, and will rise up to 300 million by 2025. In India, around 25% of the 25 million pregnancies are associated with gestational diabetes mellitus (GDM), and increasing rapidly over the time. Reported prevalence rates for GDM for Sri Lanka (13%) and Bangladesh (10%) have been described. However, in Bangladesh, estimate varies from 9.7% to 12.9% when different criteria were used. Knowledge gap: There is knowledge gap on whether a resource- and culturally-appropriate lifestyle intervention program will be more effective and cost effective relative to usual care in delaying incidence of T2D among women in South Asia. Evidence of developed countries indicate that a low-intensity lifestyle intervention, integrated with antenatal care in health system, optimizes healthy diet and attenuates physical activity decline in early pregnancy. Objective of the study: 1.To determine whether a resource- and culturally-appropriate lifestyle intervention program in Bangladesh , provided to women with prior gestational diabetes after delivery, will reduce the incidence of worsening of glycaemic status. 2. To explore whether the designated lifestyle intervention program is affordable, acceptable and scalable locally. Methods: Study design: An open-label parallel group pragmatic individual randomized controlled trial with blinded primary endpoint adjudication. The randomized controlled trial will be preceded by an intervention development and optimization phase. Intervention: Low intensity lifestyle modification program Duration: 4 years (48 months) Study settings: In Bangladesh, the investigators will conduct the intervention trial in 4 maternity care hospitals in Dhaka city. Sample size: A total of 1440 women with GDM from 24 hospitals (~60/hospital) will require for the RCT from 3 different countries. In Bangladesh, 360 participants from 4 selected maternity care hospitals (90 participants from each hospital, 45 cases and 45 controls) will be required. Inclusion Criteria: Absence of T2DM at 6±3months post-partum OGTT. Anticipated outcomes: Primary outcomes: Proportion of women with a change of glycaemic category, at or prior to final visit: Normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or T2DM; and/or impaired fasting glucose/impaired glucose tolerance to type 2 Diabetes Mellitus (DM) Secondary outcomes: Mean changes in Body weight, Mean changes in waist circumference, Mean changes in systolic blood pressure, mean changes in fasting blood glucose, increase physical activity level from low to moderate and increase fruits and vegetable consumption, incremental cost effectiveness ratio and feasibility of intervention.

NCT ID: NCT03281980 Enrolling by invitation - Child Development Clinical Trials

Effects of Psychosocial Stimulation and Cash on Children's Development and Behaviour

Start date: August 20, 2017
Phase: N/A
Study type: Interventional

Burden: In developing countries, an estimated 219 million children do not reach their maximum potentiality because of poverty and associated risk factors. More than half of the Bangladeshi children <5 years are at risk for developmental delay due to poverty and sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic expenditure on health care and fall into the vicious cycle of poverty Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor people' health and nutritional status, little is known about the effect of unconditional cash transfer and health education (HE) programmes along with psychosocial stimulation on children' cognition and behaviour. Relevance: The study will bring an opportunity to evaluate the effect of transferring unconditional cash and health education programme along with psychosocial stimulation to poor families under safetynet programme of Bangladesh Govt. in rural areas. The study will also document direct and indirect cost to measure cost effectiveness that will help in decision making to implement the project if it shows benefits to children's development. Primary Hypothesis (if any): - Unconditional cash transfer (UCT) and health education (HE) programme will improve child's cognitive, motor and language development and behaviour compared to no intervention group. - Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health education (HE) programme will will have an additive effect on Childs's cognitive, motor and language development and behaviour compared to the control groups Secondary Hypothesis: Additionally the intervention will - be cost effective, - reduce mothers' depressive symptoms and improve their self esteem - improve children's growth and household food security status - reduce domestic violence - Health seeking behaviour and health care expenditure Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early child development activities for the whole country. Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial stimulation (ii) UCT+HE and iii) Comparison group.

NCT ID: NCT03269006 Enrolling by invitation - Clinical trials for Visceral Leishmaniasis

Improved Case Detection and Vector Control for Visceral Leishmaniasis

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh. Since 2005 a national kala-azar elimination program is going on in the country. The program has preparatory, attack, consolidation and maintenance phases. The target of the program is to reduce the VL incidence less than 1 per 10,000 people at upazila (sub-district) level in VL endemic upazilas of the country. The program is heading successfully to its consolidation phase. During attack phase house to house search for VL suspects and also suspects with Post-kala-azar Dermal Leishmaniasis (PKDL) was the tool for early diagnosis of VL and PKDL cases. Indoor residual spraying with insecticide (Deltamethrin) was the method for sand fly control to reduce the transmission of the disease. Since in the consolidation phase the VL case load is many times less than that in the attack phase, house to house search for VL and PKDL cases and IRS for vector control is no more cost-effective for the program. Therefore there is a need for alternative methods for active search of VL and PKDL cases and method for sand fly control, appropriate for the consolidation phase. In the present study we propose to investigate the efficacy of Inesfly 5AIGRNG TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB 123, indoor residual spraying (IRS) with Delthamethrin against a control group Methods: A cluster randomized controlled design to measure sand fly density reduction at intervention household as well as sand fly mortality by entomological methods. Outcome measures/variables: reduction of sand fly density at intervention household and sand fly corrected mortality on intervention surfaces compare to control households/conditions.

NCT ID: NCT03263871 Recruiting - Clinical trials for Environmental Enteric Dysfunction

PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

Start date: October 14, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.

NCT ID: NCT03263403 Not yet recruiting - Clinical trials for Meningococcal Vaccine

Non Inferiority Trial of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladesh.

Start date: September 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This study will be a randomized observer -blinded controlled non-inferiority study to evaluate and compare the immunogenicity of locally produced Ingovax ACWY with Menomune®- A/C/Y/W-135 on a total of 88 healthy adult participants (18-45 years of age). 44 participants will receive locally produced Ingovax ACWY and 44 participants of comparator groups will receive Menomune® - A/C/Y/W which is produced by Sanofi Pasteur Inc. Vaccination will be done in Day 0 following the screening and pre-immunization blood sample collection and post-immunization blood will be collected at Study Day 30. Follow- up by home visit will be carried out from Study day 1-6 and clinic follow-up is scheduled upto Study day 90. The hypothesis of this study is: locally produced subcutaneous Meningococcal vaccine Ingovax ACWY is non inferior and immunogenic among adults in Bangladesh as compared to Menomune® - A/C/Y/W-135.

NCT ID: NCT03259269 Recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Expand New Drugs for TB [endTB]

Start date: February 9, 2016
Phase: N/A
Study type: Observational

This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.

NCT ID: NCT03258385 Not yet recruiting - Early Pregnancy Clinical Trials

Vitamin B12 Supplementation to Improve B12 Status and Child Development

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth defects and common complications (e.g. intrauterine growth restriction, neural tube defects), and possibly immune function impairment. The newborns and infants of B12-deficient mothers have low B12 stores at birth, further exacerbated by a very low concentration of B12 in breast milk that may hinder their growth and development. In regions such as Bangladesh, many women of reproductive age have inadequate B12 status, probably due to low intake of animal source food. Vitamin B12 intake and status in pregnancy and lactation is potentially insufficient to prevent impaired child development and immune function related to inadequate B12 status. The investigators hypothesize that prolonged vitamin B12 supplementation through fortified milk starting from early pregnancy up to 6 mo-postpartum will improve: (1) biomarkers of vitamin B12 status in mothers-infant pairs (2) vaccine specific adaptive immunity in infants; (3) neurological and cognitive function in infants.

NCT ID: NCT03225586 Recruiting - Cancer Clinical Trials

Prospective Urban Rural Epidemiology Study

PURE
Start date: January 1, 2002
Phase: N/A
Study type: Observational

To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component).