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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Protocols for managing acute malnutrition in communities have not changed much in over 20 years, often involving complex treatments and supply challenges that limit care coverage. This research aims to test two new simplified community-based approaches to improve coverage for children recovering from severe and moderate acute malnutrition. The study focuses on evaluating a family-led mid-upper arm circumference MUAC screening method as a way for caregivers to monitor their childs health at home compared to usual health facility follow-up and standard care. The study assigns children who have recovered from malnutrition treatment into one of three groups one receives nutrition, infant and young child feeding IYCF, and water, sanitation, and hygiene WASH education with regular health worker screenings and a final 6-month visit another group gets standard care with scheduled follow-up visits at 1, 3, and 6 months and the last group receives standard care plus family MUAC training for the primary caregiver and a final 6-month visit. This randomized, double-blind trial compares these three approaches to see which best identifies relapse to malnutrition. Participants will be monitored for 6 months, during which researchers will track relapse episodes of acute malnutrition, nutritional status via weight-for-height and MUAC measurements, rates of recovery from relapse, mortality, hospitalizations, and loss to follow-up. Caregivers will be involved in monitoring through training or health worker visits, and the study aims to assess how well family MUAC screening works as a self-referral strategy versus scheduled clinical follow-up. The total study period for each child is 6 months after recovery from initial treatment.

Age: 6Months - 59MonthsAll GendersPhase Not Applicable
3 locations
E

Actively Recruiting

Researchers are studying new simplified treatment approaches for moderate acute malnutrition MAM in children aged 6 to 59 months. The study aims to evaluate two modified dosage regimens of ready-to-use therapeutic food RUTF compared to the current standard dosage of ready-to-use supplementary food RUSF. This research addresses challenges in current community-based management of acute malnutrition that has seen little change in over 20 years and seeks to improve program coverage for malnourished children. The trial randomly assigns participants to one of three groups receiving either the standard RUSF dose 1 sachet daily providing 535 kcal, a lower dose of RUTF 1 sachet daily providing 500 kcal, or a higher dose of RUTF 2 sachets daily providing 1000 kcal. These dietary supplements are given for up to 16 weeks to monitor recovery and nutritional status. The study includes double-blind masking to compare safety, efficacy, and cost-effectiveness of these modified doses. Participants will be assessed weekly during treatment for weight gain, mid-upper-arm circumference changes, height growth, and body composition via bioelectrical impedance analysis. Immunological function, rates of acute illness, hospitalization, mortality, and treatment duration are also monitored weekly. After recovery, medium-term outcomes such as relapse rates and nutritional gains will be evaluated for up to six months. The study aims to measure short- and medium-term nutritional recovery and cost efficiency among the treatment groups.

Age: 6Months - 59MonthsAll GendersPhase Not Applicable
3 locations
T

Actively Recruiting

Researchers are evaluating two simplified dosing methods of Ready-to-Use Therapeutic Food RUTF for treating severe acute malnutrition SAM in children aged 6 to 59 months. The study aims to improve program coverage by testing fixed-dose regimens against the current weight-based dosing approach. This research is conducted by Action Against Hunger USA to address longstanding challenges in managing acute malnutrition with complex protocols and supply issues. The trial includes three groups one receiving standard weight-based RUTF dosing at 150-200 kcalkgday, another given two sachets 1000 kcal of RUTF daily, and a third group receiving two sachets daily while severely malnourished, then reducing to one sachet as the childs condition improves. Amoxicillin is also given following Ethiopian national guidelines. The study is randomized, double-blinded, and runs for up to 16 weeks, focusing on nutritional recovery and cost-effectiveness. Participants will be monitored weekly for weight, mid-upper arm circumference MUAC, height, body composition via bioelectrical impedance, and immune function through blood tests. Researchers will track illness rates, mortality, hospitalization, and treatment duration during the trial and assess medium-term outcomes up to six months post-recovery. The study measures both short-term recovery from SAM and longer-term nutritional status and relapse rates, with safety and cost-efficiency also evaluated throughout.

Age: 6Months - 59MonthsAll GendersPhase Not Applicable
3 locations