Safety and tolerance of ester-C compared with regular ascorbic acid.
The goal of this randomized, double-blind crossover clinical trial in 50 healthy volunteers sensitive to acidic foods was to evaluate whether Ester-C calcium ascorbate causes fewer epigastric adverse effects than are produced by regular ascorbic acid (AA). Volunteers were randomly separated into 2 groups of 25. The study comprised an observation period of 9 days (phase 1 medication for 3 consecutive days, washout phase for 3 consecutive days, phase 2 medication for 3 consecutive days). Participants took 1000 mg vitamin C as Ester-C during phase 1 of the study followed by 1000 mg of vitamin C as AA during phase 2, or vice versa. During the course of the study, 3 examinations for the evaluation of epigastric adverse effects were performed (on days 0, 3, and 9). Participants used a diary to record epigastric adverse effects on a daily basis. In total, 28 (56%) of 50 participants reported 88 epigastric adverse effects of mild to moderate intensity. Of these 88 adverse effects, 33 (37.5%) occurred after intake of Ester-C and 55 (62.5%) were noted after intake of AA. The tolerability of Ester-C was rated "very good" by 72% of participants, whereas AA was rated "very good" by only 54%. This difference is statistically significant (P<.05). Investigators concluded that Ester-C compared with AA caused significantly fewer epigastric adverse effects in participants sensitive to acidic foods and that Ester-C is much better tolerated.
Gruenwald
Joerg
J
Analyze and Realize AG, Berlin, Germany.
Graubaum
Hans-Joachim
HJ
Busch
Regina
R
Bentley
Christine
C
D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000009:adverse effects* / Q000737:chemistry; D001205:Ascorbic Acid / Q000009:adverse effects* / Q000737:chemistry; D018592:Cross-Over Studies; D003683:Dehydroascorbic Acid / Q000009:adverse effects / Q000737:chemistry; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013912:Threonine / Q000009:adverse effects* / Q000737:chemistry
D000975:Antioxidants; D004338:Drug Combinations; C069207:calcium ascorbate; D013912:Threonine; D001205:Ascorbic Acid; D003683:Dehydroascorbic Acid