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Growth Disorders clinical trials

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NCT ID: NCT03312049 Completed - Stunting Clinical Trials

Aflatoxin Birth Cohort Study Nepal (AflaCohort)

AflaCohort
Start date: July 6, 2015
Phase:
Study type: Observational

The study focuses on the causal relationship between mycotoxin exposure (particularly aflatoxin B1), birth outcomes, and height for age among young children in Nepal. Previous studies have shown a strong association of stunting with mycotoxin exposure yet causality has not been proven. Thus, this study will provide a better understanding of the association between maternal and/or early life mycotoxin exposure (rates in the blood and breast milk) and infant and young child growth. This information is essential if we are to more fully understand and effectively address the high rates of stunting in Asia.

NCT ID: NCT03299218 Completed - Stunting Clinical Trials

Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan

Start date: May 26, 2017
Phase: N/A
Study type: Interventional

Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations. Although, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are quite evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014. Given the alarming situation of child malnutrition in district Rahim Yar Khan, the World Food Program (WFP) Pakistan is proposing an intervention program comprised of cash-based transfers, specialized nutritious foods and behaviours change communication to prevent stunting in district Rahim Yar Khan, province Punjab. The interventions will be delivered through the existing health system and Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. Therefore, the Department of Paediatrics and Child Health, Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan to assess the effectiveness of the WFP interventions on process and outcome indicators.

NCT ID: NCT03229629 Completed - Malnutrition Clinical Trials

What Promotes Healthy Eating? The Roles of Information,Affordability,Accessibility,Gender, and Peers on Food Consumption

Start date: June 25, 2017
Phase: N/A
Study type: Interventional

Pre-school undernutrition is a global problem with life long adverse consequences. One form of undernutrition, chronic undernutrition or stunting, affects 171 million children under the age of 5 worldwide. 35% of these children live in Africa. In Ethiopia, the focus of this study, in 2014, 44.5% of children under 5 were stunted. Stunting is the consequence of several factors including low birth weights, sub-optimal infant and complementary feeding practices and repeated illness. In Ethiopia, complementary feeding is sub-optimal; only 4% of children aged 6-24 months met the minimum dietary diversity recommended by WHO. The investigators hypothesize four main reasons why many children and mothers in Ethiopia fall short of best practice in terms of meeting nutritional needs and providing appropriate childcare. (i) Lack of information on healthy eating and appropriate child-feeding practices; (ii) Limited affordability; (iii) Limited accessibility to markets and diverse food items; and (iv) Limited peer effects in spreading information and adopting new practices. This study will assess the efficacy of the interventions that address these four barriers to optimal complementary feeding practices in Ethiopia. Using a cluster randomized control design, mother-father-child pairs in two localities, Holeta and Ejere will be enrolled. Treatment will be randomized at the garee (village) level. There will be five treatment arms and a control group: T1, weekly maternal nutrition BCC sessions for four months; T2, weekly maternal nutrition BCC sessions for four months and weekly paternal nutrition BCC sessions for three months; T3, receipt of a food voucher for six months; T4, weekly maternal nutrition BCC sessions for four months and receipt of a food voucher for six months; T5 weekly maternal nutrition BCC sessions for four months and weekly paternal nutrition BCC sessions for three months and receipt of a food voucher for six months; and C, a control group. Within household, recipient of voucher (mother or father) will be randomly selected.

NCT ID: NCT03181178 Completed - Growth Disorders Clinical Trials

Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian Infants

TRIUMF
Start date: February 2013
Phase: N/A
Study type: Interventional

Prevention of malnutrition in infants and children requires access and intake of nutritious food starting at birth with exclusive breastfeeding for the first 6 months of life, breastfeeding in combination with complementary foods from 6-24 months of age, access to clean drinking water and sanitation, access to preventive and curative health care (including prenatal). In Ghana, the Demographic and Health Survey of 2014 reports rates of stunting, wasting and underweight in children aged 0-59 months are 28%, 14% and 9% respectively. Furthermore, height for age starts dropping from age 4-6 months with children aged 6-23 months being more likely to be stunted (40%) than those below 6 months (4%). Infant and young child feeding data show that for breast-fed children ranging from 6 months through 35 months of age, cereals are predominantly the first foods introduced in the diet (6-8 months of age). As the child grows older, consumption of fruits rich in Vitamin A, other fruits and vegetables and meat, fish, poultry and eggs are reported by the mothers. The Demographic and Health Survey (DHS) found that the proportion of breast fed children aged 6-23 months who received a recommended variety of foods the minimum number of times per day increases with child's age from 28% in children 6-8 months to 50% in children aged 18-23 months. The study objective is to examine the effect of providing a macro- and micro-nutrient fortified complementary food supplement (KokoPlusTM) on growth and nutritional status of Ghanaian infants.

NCT ID: NCT03079583 Completed - Zinc Deficiency Clinical Trials

The Efficacy of Zinc-biofortified Rice in Bangladeshi Children

ZARI
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

To assess the efficacy of the zinc biofortified rice on plasma zinc concentrations in infants from a rural area of Bangladesh.

NCT ID: NCT03024710 Completed - Growth Disorders Clinical Trials

Promotion of Complimentary Feeding Practices in Bangladesh

Start date: January 2011
Phase: N/A
Study type: Interventional

Infant feeding practices and nutritional status among children is interrelated and link is well established. Incidence of malnutrition sharply rises during 6-9 months of age in most of the developing countries which coincide with the period of complimentary feeding (CF). This prospective randomized trial will be implemented in ongoing health and demographic surveillance system of Matlab, ICDDR,B and will be nested into an ongoing maternal and child health services area. Area of community health workers (four blocks) will be divided into two pairs and each pair will be randomly assigned into intervention or control groups. The eligible and consented mother-infant newborn will be recruited either into an intervention or control groups based on the areas of the paired block. The mothers and family members of the intervention area will receive intensive counseling on complementary feeding practices through community health workers. In total about 360 mother-infant pair will be recruited in the study for each site. Data on children's anthropometry (weight and lengths), information on complementary feeding practices and related covariates will be collected through trained research staffs. Data will be evaluated on reduction of burden of malnutrition (stunting, underweight, wasting) and complimentary feeding index between intervention and control groups.

NCT ID: NCT02839148 Completed - Clinical trials for Nutritional Stunting

Development of Appetite Measuring Tool and Appetite Status of Stunted Children

Start date: April 2016
Phase: N/A
Study type: Interventional

This study will provide a tool for researchers to measure important outcomes in relation to trial of intervention to reduce or prevent stunting. Hypothesis: We assume that appetite score will be associated with improvement in growth and development parameters of children given the nutrition and psychosocial stimulation intervention Objectives: To explore maternal perception regarding childhood stunting To develop and validate an appetite measuring tool To assess the appetite status of young children To examine the relationship between appetite score, growth and development, potential biomarkers of appetite, child food intake and intestinal inflammation of the children. Methods: In the first phase, a qualitative study will be conducted to explore maternal perception regarding childhood stunting and to develop a tool- the "Early Childhood Appetite and Satiety Tool"(ECAST) using mixed method approach (qualitative and quantitative). In the second phase, a community-based trial will be conducted with 50 stunted children of aged 12-18 months, living in urban slums of Dhaka, and 50 age-sex matched control children (non-stunted).

NCT ID: NCT02580032 Completed - Clinical trials for Growth Hormone Deficiency in Children

Validation of Two Measures for Growth Hormone Deficiency in Children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD)

Start date: October 5, 2015
Phase:
Study type: Observational

This study is conducted in Europe and the United States of America (USA). The aim of the study is to validate two measures for growth hormone deficiency in children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD).

NCT ID: NCT02428296 Completed - Genetics Clinical Trials

Study of Sirolimus Therapy for Segmental Overgrowth Caused by Somatic PI3K Activation

Start date: April 23, 2015
Phase: Phase 2
Study type: Interventional

Background: - PIK3CA-related overgrowth spectrum (PROS) is caused by changes in the PIK3CA gene. This gene makes a protein that communicates with other proteins in the body to cause cells to grow. Alterations in PIK3CA change the chemical signals in the body and cause overgrowth in fatty, vascular and other tissues. Sirolimus is a drug that reduces the signals sent by one of the proteins in this chemical signaling pathway. Researchers want to learn whether the drug sirolimus can reduce or stabilize some of the overgrowth that patients with PROS experience. Objectives: - To measure how the overgrowth of patients with PROS changes over time and whether taking a drug called sirolimus can reduce or stabilize a person s overgrowth. Eligibility: - People ages 3 to 65 years old with a confirmed mutation or alteration of the PIK3CA gene in the person s affected tissues (a somatic mutation). Design: - Participants will be screened with medical history and genetic counseling. - First 6 months: Participants will have their overgrowth monitored. - Next 6 months: Participants will take sirolimus once or twice a day. - Participants will have to visit the clinic several times, and stay in the area for 4 to 5 days each time. - Participants will have a one month-long visit to the clinic. - During clinic visits, participants will have: - Blood and urine tests. - Photographs of their physical features. - Scans, including an MRI and DEXA, and possibly x-rays and CT scans. - For the MRI and CT scans, participants will lie in a machine that takes pictures of their body. - The DEXA involves a small amount of radiation. - They may have: - Non-invasive heart function tests. - Lung function tests. - Participants will have several blood and urine tests between visits. - Participants will complete surveys and keep a diary of their treatment and side effects. - Participants may visit other health specialists or undergo other tests based on side effects. - One month after stopping the study drug, participants will have 1 clinic visit.

NCT ID: NCT02422953 Completed - Malnutrition Clinical Trials

Stunting Prevention Project in Thatta and Sujawal Districts, Sindh Province, Pakistan

Start date: August 2014
Phase: N/A
Study type: Interventional

Widespread food insecurity and malnutrition are largely the main impairing factors for human capital development in Pakistan. Rates of chronic malnutrition are very high, and acute malnutrition is critical: 44% of children under five are stunted and nationwide global acute malnutrition (GAM) rates amongst children under five exceed the WHO critical threshold of 15%. Nutritional status trends also show a deteriorating situation since 1994, when stunting rates were at 36%. This study evaluates the effectiveness of food based interventions to prevent stunting among children under-five years with focus on window of opportunity (1000 days from conception to 2 years) for addressing stunting. Pregnant women, lactating mothers and children 6-59 months will receive supplements on monthly basis in intervention areas, while participants in control areas will receive routine public health services available in the study area.