Clinical trials: Choline Nutrition
Infant Malnutrition
The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi
The Mazira Project is a study of the effect of egg consumption on growth, development and gut health of infants in Malawi. The study randomly assigns infants to receive one egg per day over six months or to receive an equivalent…
- Trial name
- NCT03385252
- Testing
- Eggs, Visits
- Where
- Malawi
- Volunteers
- 662 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Severe Acute Malnutrition, Cognitive Impairment
Choline to Improve Malnutrition and Enhance Cognition
The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi.
- Conditions
- Severe Acute Malnutrition, Cognitive Impairment, Wasting, Kwashiorkor
- Trial name
- CHIME-SAM (NCT06154174)
- Testing
- C-RUTF (Ready-to-Use Therapeutic Food with added choline), S-RUTF (Ready-to-Use Therapeutic Food without added choline), Amoxicillin
- Where
- 10 sites in Malawi
- Volunteers
- 1,500 people
- Sponsor
- Washington University School of Medicine
Fatty Liver
Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
OBJECTIVES: I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition.
- Trial name
- NCT00004697
- Testing
- choline chloride
- Volunteers
- 15 people
- Sponsor
- University of Texas
Fatty Liver, Liver Fibrosis
Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic…
- Conditions
- Fatty Liver, Liver Fibrosis, Obesity, Metabolic Syndrome
- Trial name
- NCT01934777
- Testing
- Docosahexaenoic Acid plus Vitamin E plus choline
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Bambino Gesù Hospital and Research Institute
Healthy
Choline Nutritional Status: Development of a Biomarker Panel
People who eat diets low in choline should deplete their choline (Cho) stores, and measurements of Cho pool size using isotope dilution should reflect this depletion.
- Trial name
- NCT03726671
- Testing
- 25% Cho diet, 50% Cho diet, 100% Cho diet
- Where
- United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Prader-Willi Syndrome
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.
- Trial name
- NCT03714373
- Testing
- DCCR
- Where
- 28 sites in United States, United Kingdom
- Volunteers
- 115 people
- Sponsor
- Soleno Therapeutics, Inc.
Prader-Willi Syndrome
An Open-Label Study of DCCR Tablet in Patients With PWS
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.
- Trial name
- NCT04086810
- Testing
- DCCR
- Sponsor
- Soleno Therapeutics, Inc.
Intestinal Failure-associated Liver Disease
Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition
This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week.
- Trial name
- THRIVE-1 (NCT05011370)
- Where
- 15 sites in United States, Denmark and 2 more
- Volunteers
- 80 people
- Sponsor
- Protara Therapeutics
Prader-Willi Syndrome
A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
The purpose of this is study is to evaluate the effects of DCCR (diazoxide choline controlled release tablets) in children and adults with Prader-Willi syndrome.
- Trial name
- NCT03440814
- Testing
- DCCR
- Where
- 29 sites in United States, United Kingdom
- Volunteers
- 127 people
- Sponsor
- Soleno Therapeutics, Inc.
Healthy
Developing a Biomarker Panel to Assess Choline Nutritional Status
People who eat diets low in choline (LC) should deplete their choline (Cho) stores, and measurements of Cho pool size using isotope dilution should reflect this depletion.
- Trial name
- NCT03234062
- Testing
- 25% Cho diet, 50% Cho diet, 100% Cho diet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Cystic Fibrosis
Choline Nutrition in Children With Cystic Fibrosis (CF)
Cystic Fibrosis (CF) is a complex disease with a wide range of clinical problems. Despite enzyme replacement therapy, children with cystic fibrosis (CF) may still have problems absorbing some nutrients.
- Trial name
- NCT00686361
- Testing
- Choline supplementation
- Where
- Canada
- Volunteers
- 34 people
- Sponsor
- University of British Columbia
Cystic Fibrosis
Choline Nutrition in Children With Cystic Fibrosis
Cystic fibrosis (CF) is the most common lethal, inherited disorder among Caucasians. Choline is an essential vitamin and as a methyl donor is critically needed to support the normal metabolism.
- Trial name
- NCT01070446
- Testing
- Vitamin: Choline Bitartrate (2-hydroxyethyl) trimethylammonium salt 1:1
- Where
- Canada
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Prader-Willi Syndrome
Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
Prospective observational study developed to generate more evidence of the safety profile, clinical characteristics and outcomes of patients with PWS treated with VYKAT XR.
- Trial name
- NCT07450664
- Testing
- VYKAT XR
- Where
- 25 sites in United States
- Volunteers
- 200 people
- Sponsor
- Soleno Therapeutics, Inc.
Choline Deficiency, Liver Injury
Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
TARA-001-301 is a Phase 2b/3 randomized Open-Label Dose-Selection study with an Open-Label Extension and randomized Double-Blind, Placebo-Controlled Study with Open-Label Extension to investigate the safety and efficacy of…
- Trial name
- THRIVE-3 (NCT06910943)
- Testing
- Choline Chloride for Injection
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 129 people
- Sponsor
- Protara Therapeutics
Cystic Fibrosis
Choline Nutritional Status Of Children With Cystic Fibrosis X-Sectional Study
Cystic fibrosis (CF) is the most common lethal, inherited disorder among Caucasians. Choline is an essential vitamin and as a methyl donor is critically needed to support the normal metabolism.
- Trial name
- NCT01150136
- Where
- Canada
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Choline Deficiency, Vitamin B-12 Deficiency
Cracking the Egg Potential: Improving Young Child Nutrition in Ecuador
The proposed study will fill an important gap in the literature by examining, through a randomized controlled trial, the effect of egg consumption on biochemical markers of choline, vitamin B-12, lipids, and amino acids in young…
- Conditions
- Choline Deficiency, Vitamin B-12 Deficiency, Lipids Deficiency, Amino Acids Deficiency
- Trial name
- NCT02446873
- Testing
- Egg supplementation
- Where
- Ecuador
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Genomic and Metabolomic Variations, Preterm Birth
Effects of Genomic and Metabolomic Variations of Choline on Risk of Preterm Birth and Clinical Outcomes in Preterms
The incidence of preterm birth increases annually. Premature delivery has become the leading cause of neonatal illness and death.
- Conditions
- Genomic and Metabolomic Variations, Preterm Birth, Total Parenteral Nutrition
- Trial name
- NCT02841813
- Testing
- No intervention
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Prader-Willi Syndrome
Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome
This is a single-center, open-label, single-arm study with a double-blind, placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose of about 1.5 mg/kg (maximum starting dose of 145 mg) and are…
- Trial name
- NCT02034071
- Testing
- DCCR
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Essentialis, Inc.
Severe Acute Malnutrition in Childhood
Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza
This is a randomized clinical trial to learn whether ready-to-use therapeutic foods enriched with choline and docosahexaenoic acid (DHA) together with psychosocial stimulating activities work well to improve child development in…
- Trial name
- BRIGHTSAM (NCT06781918)
- Testing
- Ready to Use Therapeutic Food (RUTF), Psychosocial stimulation
- Where
- Tanzania
- Volunteers
- 800 people
- Sponsor
- National Institute for Medical Research, Tanzania
Prader-Willi Syndrome
Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.
- Trial name
- NCT05701774
- Testing
- DCCR
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 77 people
- Sponsor
- Soleno Therapeutics, Inc.