Cystadane (Betaine) - Summary

CYSTADANE SUMMARY

Cystadane (betaine anhydrous for oral solution) is an agent for the treatment of homocystinuria.   It contains no ingredients other than anhydrous betaine. Cystadane is a white, granular, hygroscopic powder, which is diluted in water and administered orally.

Cystadane® (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels.  Included within the category of homocystinuria are:  

• Cystathionine beta-synthase (CBS) deficiency
• 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
• Cobalamin cofactor metabolism (cbl) defect
  

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NEWS HIGHLIGHTS

Published Studies Related to Cystadane (Betaine)

Evaluation of the clinical efficacy of a betaine-containing mouthwash and an intraoral device for the treatment of dry mouth. [2011.09.22]
J Oral Pathol Med (2011) Objective: An evaluation is made of the efficacy and safety of an intraoral device with a betaine (BET)-containing mouthwash in treating xerostomia. Methods: A total of 105 patients with dry mouth (xerostomia) were included in a randomized, non-blinded, parallel-group, controlled clinical trial...

Influence of betaine and conjugated linoleic acid on development of carcass cuts of Iberian pigs growing from 20 to 50 kg body weight. [2011.07]
Twenty Iberian gilts (20 kg body weight, BW) were fed diets containing no betaine or conjugated linoleic acid (CLA) (Control), 0.5% betaine, 1% CLA, or 0.5% betaine+1% CLA. Additionally, 5 pigs were killed at 20 kg BW for the initial points of the allometric equations.

Long-term effect of betaine on risk factors associated with the metabolic syndrome in healthy subjects. [2011.01]
CONCLUSIONS: Betaine had no effect on serum lipid profile in long term in young healthy subjects. The lowering effect on plasma homocysteine concentration was weak.

Consumption of wheat aleurone-rich foods increases fasting plasma betaine and modestly decreases fasting homocysteine and LDL-cholesterol in adults. [2010.12]
There is strong evidence that whole-grain foods protect against heart disease. Although underlying mechanisms and components are unclear, betaine, found at high levels in wheat aleurone, may play a role... Although this supports a role for betaine in the protective effects of whole grains, concomitant decreases in LDL suggest more than one component or mechanism may be responsible.

Effect of graded levels of dietary betaine on ileal and total tract nutrient digestibilities and intestinal bacterial metabolites in piglets. [2010.12]
The study was conducted to investigate the effects of graded dietary inclusion levels of betaine on ileal and total tract nutrient digestibilities and intestinal bacterial metabolites in piglets. A total of eight barrows with an average initial body weight of 7.9 kg were randomly allocated to one of the four assay diets with two pigs per treatment in four repeated measurement periods.

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Clinical Trials Related to Cystadane (Betaine)

Effects of Betaine Supplementation on Strength and Muscle Creatine Content [Completed]
It has been suggested that betaine supplementation may improve muscle strength by increasing muscle creatine content. However, there is no data supporting this assumption. The investigators speculate that betaine supplementation could enhance intramuscular creatine content, which would result in strength improvements.

Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria [Completed]
The aim of this study is to assess the efficacy and safety of betaine in reducing urine oxalate excretion of Type 1 Primary Hyperoxaluria (PHI) patients. Hypothesis: Betaine will effectively reduce urine oxalate excretion in Primary Hyperoxaluria Type I patients.

A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh [Completed]
Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L. Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies on one-carbon metabolism and involves two methylation steps; both utilize S-adenosylmethionine (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins including folate and B12 for the recruitment and transfer of methyl groups, but other nutrients, including choline and betaine, also contribute to the methyl pool. Our recent findings from a cross-sectional study of Bangladeshi adults exposed to a wide range of As concentrations in drinking water show that plasma choline and betaine concentrations are positively associated with As methylation. These findings suggest that choline and/or betaine may play an important role in As methylation and elimination and that simple interventions may have therapeutic potential for the many populations at risk for As-induced health effects. The investigators aim to recruit and follow 60 participants for this pilot study which will allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor participants for any potential side effects, 3) identify any difficulties that might be encountered in daily follow-up, and 4) generate preliminary data regarding the effects of choline and/or betaine supplementation on arsenic methylation.

Betaine in Patients With Nonalcoholic Steatohepatitis [Completed]
To assess the safety and efficacy of betaine in patients with NASH on markers of disease severity such as liver histology, liver biochemistries, and health related quality of life.

Choline Dehydrogenase and Sperm Function: Effects of Betaine [Recruiting]
The ability of sperm to swim is important for normal fertility. Men with a genetic variation in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient called betaine (found normally in the diet as a part of many foods such as spinach, beets and grain products). This study tests whether treatment with betaine is safe and whether it can normalize energy production in sperm of these men and restore normal swimming ability.

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Reports of Suspected Cystadane (Betaine) Side Effects

Blood Homocysteine Increased (6),  Drug Dose Omission (3),  Pyrexia (3),  Maternal Exposure During Pregnancy (3),  Convulsion (3),  Diarrhoea (3),  Abdominal Pain (2),  Nasopharyngitis (2),  Partial Seizures (2),  Abortion Induced (2), more >>