Oral administration of cofactors, 1g nicotinamide riboside, 3g L-carnitine, 20g serine and 5g N-acetylcystein, first as single compounds, then combined, on 5 days

Healthy

Oral administration of 1g nicotinamide riboside, 3g L-carnitine, 20g serine and 5g N-acetylcystein, first as single compounds, then combined, on 5 days

Cofactors

Hanns-Ulrich Marschall

Sahlgrenska Academy

Kinetics of Metabolic Cofactors in NAFLD

Kinetics of Metabolic Cofactors After Oral Supplementation in Healthy Subjects

Plasma levels of nicotinamide riboside by UPLCMSMS at 8 time points during 24h after administration

Plasma levels of L-carnitine (nM) measured by UPLCMSMS at 8 time points during 24h after administration

Plasma levels of L-serine (nM) measured by UPLCMSMS at 8 times points during 24h after administration

Plasma levels of N-acetylcystein (nM) measured by UPLCMSMS at 8 times points during 24h after administration

Untargeted metabolomic analysis using mass spectrometry. (Untargeted = not pre-specified in terms of outcome)

Changes in the plasma level of inflammation related proteins associated with the supplementation of metabolic co-factors.

Professor, University Hospital Consultant

Sahlgrenska University Hospital, Sweden

Karolinska Institutet

Chalmers University of Technology

L-carnitine (25, 50, or 100mg/kg IV) will be given, 30-60 minutes prior to the initiation of CPB, and a second dose ~2 hr. following separation from CPB (with a minimum of 4 hrs from initial dose). The first 5 subjects will receive 25 mg/kg, with an escalation of dose after each 5 subjects enrolled. The study drug will be brought to the operating room and administered over 5 minutes by the anesthesiologist after an IV has been placed. Prior to the administration of the study drug, and again 24 and 48 hrs after CPB, 3.0 ml of blood will be collected for determinations of carnitine levels (free, total, and acylcarnitine), mitochondrial function, ROS and bioavailable NO as described in Aim 3A. Additional blood (0.5-1.0 ml) will be obtained to determine carnitine levels before CPB, and then before and 0.5, 1.5, 3, 5, 9, 12, and 24h after the second dose.

Heart Septal Defects, Ventricular

Atrioventricular Septal Defect

IV L-carnitine

University of California San Francisco

Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow

Phase 1 Study of the Safety and Pharmacokinetics of Perioperative IV L-carnitine Administration in Patients With Congenital Heart Disease With Increased Pulmonary Blood Flow

Estimates of PPA and right ventricular (RV) function by transesophageal ECHO (TEE)

University of California, San Francisco

The patients will be randomized into two groups:
Group I (Physiotherapy + Placebos) Group II (Physiotherapy + Valproate and Levocarnitine)

All patients will be randomized into two groups:
Group I (Physiotherapy + Placebos) Group II (Physiotherapy + Valproate and Levocarnitine)

Spinal Muscular Atrophy

All patients with diagnosis of SMA aged 2-15 years already registered in Myopathy Clinic of AIIMS will be recalled. Information will be sent to all Government Hospitals in Delhi that such a study is currently in progress and all the referrals will also be recruited. These patients and all those newly diagnosed at Myopathy Clinic, AIIMS will be randomized into two groups:
Group I (Physiotherapy + Placebos) Group II (Physiotherapy + Valproate and Levocarnitine)
The investigators will be blinded to the code of the medicine. It will be broken only at the end of the study or if there are any significant side effects. So one group will receive Valproate and levocarnitine and other group will receive Placebo and placebo.

Valproate, Levocarnitine

Placebo

All India Institute of Medical Sciences

Valproate and Levocarnitine in Children With Spinal Muscular Atrophy

Randomized Placebo Controlled Trial of Valproate and Levocarnitine in Children With Spinal Muscular Atrophy Aged 2-15 Years

Baseline assessment will include a detailed muscle charting on a 5 point scale as per the principles of manual muscle testing by a child physiotherapist.Patients will be clinically re-evaluated at 12, 24, 36 and 52 weeks by a detailed muscle charting on a 5 point scale as per the principles of manual muscle testing by a child physiotherapist.

Baseline functional status will be assessed using modified Hammersmith Functional Motor Scale (MHFMS) score. Change in functional measure using modified Hammersmith Functional Motor Scale (MHFMS) score will be measured at 12, 24, 36 and 52 weeks

Baseline Forced vital capacity (FVC) followed by change in Forced vital capacity (FVC) at 12, 24, 36 and 52 weeks will be measured.

All patients will be assessed for side effect profile of valproate (dyspepsia, weight gain, dysphoria, fatigue, dizziness, drowsiness, hair loss, headaches, nausea, sedation and tremors) at 12, 24, 36 and 52 weeks.

Hemogram and Liver Function tests of all recruited patients will be done at 24 and 52 weeks

Serum Valproate levels of all subjects will be done at 52 weeks

Sheffali Gulati

Additional Professor, Department of Pediatrics

All India Institute of Medical Sciences, New Delhi

Major Depressive Disorder

Creatine monohydrate

Placebo will be given in the same way and appearance as the active treatment

Beer Sheva Mental Health Center

Creatine as a New Therapeutic Strategy in Depression

A Double-blind, Parallel, Randomized, add-on Clinical Trial of Creatine Versus Placebo Added to Antidepressant Treatment of Patients With Major Depressive Episode.

carnitine/mual

Kinetics of Metabolic Cofactors in NAFLD

Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow

Valproate and Levocarnitine in Children With Spinal Muscular Atrophy

Creatine as a New Therapeutic Strategy in Depression

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