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Controlled trials of very high dose folic acid, vitamins B12 and B6, intravenous folinic acid and serine for treatment of hyperhomocysteinemia in ESRD.
J Nephrol 2003 Jul-Aug; 16(4):522-34JN

Abstract

BACKGROUND

Hyperhomocysteinemia is seen in most hemodialysis (HD) patients and is an independent risk factor for cardiovascular disease. Homocysteine metabolism via remethylation requires activated folate and vitamin B12 and metabolism via transsulfuration requires serine and vitamin B6. Prior studies have shown highly variable effects of supplemental B vitamin and folate therapy for hyperhomocysteinemia. We undertook a fully controlled trial with abnormally high doses of folic acid alone or with supplemental vitamin B6 and B12 compared with active folate alone or with serine.

METHODS

Two prospective studies were undertaken in hemodialysis patients. In the first study (protocol A), hyperhomocysteinemia was treated in 77 patients with 30 or 60 mg folic acid with or without vitamins B6 and B12 for eight weeks and compared with matching placebos. In the second study (protocol B), hyperhomocysteinemia was treated in 37 patients with intravenous folinic acid given alone or with serine and compared with matching placebos. All patients received the standard of care treatment with a multivitamin tablet before and throughout the protocol to test the hypothesis that additional therapy is required over and above the routine therapy for maximum reduction in total homocysteine (tHcy).

RESULTS

Normal volunteers; The mean (SD) tHcy of 128 normal subjects was 6.5 (4) micromol/L. Protocol A; Plasma folate increased significantly in the groups given folic acid at both four and eight weeks (P = 0.0001 at both time points). Plasma vitamin B12 was significantly increased at four weeks (P = 0.0018) but not at eight weeks (P = 0.064) in those given Vitamin B12. However, tHcy did not differ between treatment groups at baseline (P = 0.63), four weeks (P = 0.79) or eight weeks (P = 0.74). Protocol B: Plasma folate increased significantly at four weeks in those receiving folinic acid (P = 0.0001) but tHcy was not significantly different between groups (P = 0.92). In neither study was there any significant change in tHcy comparing before and during any treatment intervention.

CONCLUSIONS

In our studies high dose oral folic acid, intravenous folinic acid, vitamins B6 and B12 and oral serine were ineffective at lowering tHcy in patients on hemodialysis when given folic acid, folinic acid serine or B vitamins in addition to routine folic acid and B vitamin supplements.

Authors+Show Affiliations

Division of Nephrology and Hypertension, Georgetown University Hospital, Washington, DC 20007, USA. goninj@gunet.georgetown.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Controlled Clinical Trial
Journal Article
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

14696754

Citation

Gonin, Joyce M., et al. "Controlled Trials of Very High Dose Folic Acid, Vitamins B12 and B6, Intravenous Folinic Acid and Serine for Treatment of Hyperhomocysteinemia in ESRD." Journal of Nephrology, vol. 16, no. 4, 2003, pp. 522-34.
Gonin JM, Nguyen H, Gonin R, et al. Controlled trials of very high dose folic acid, vitamins B12 and B6, intravenous folinic acid and serine for treatment of hyperhomocysteinemia in ESRD. J Nephrol. 2003;16(4):522-34.
Gonin, J. M., Nguyen, H., Gonin, R., Sarna, A., Michels, A., Masri-Imad, F., ... Wilcox, C. S. (2003). Controlled trials of very high dose folic acid, vitamins B12 and B6, intravenous folinic acid and serine for treatment of hyperhomocysteinemia in ESRD. Journal of Nephrology, 16(4), pp. 522-34.
Gonin JM, et al. Controlled Trials of Very High Dose Folic Acid, Vitamins B12 and B6, Intravenous Folinic Acid and Serine for Treatment of Hyperhomocysteinemia in ESRD. J Nephrol. 2003;16(4):522-34. PubMed PMID: 14696754.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Controlled trials of very high dose folic acid, vitamins B12 and B6, intravenous folinic acid and serine for treatment of hyperhomocysteinemia in ESRD. AU - Gonin,Joyce M, AU - Nguyen,Hien, AU - Gonin,René, AU - Sarna,Avina, AU - Michels,Anne, AU - Masri-Imad,Faye, AU - Bommareddy,Geeta, AU - Chassaing,Christophe, AU - Wainer,Irving, AU - Loya,Asif, AU - Cary,Douglas, AU - Barker,Lew F, AU - Assefi,Ali, AU - Greenspan,Robert, AU - Mahoney,David, AU - Wilcox,Christopher S, PY - 2003/12/31/pubmed PY - 2004/2/13/medline PY - 2003/12/31/entrez SP - 522 EP - 34 JF - Journal of nephrology JO - J. Nephrol. VL - 16 IS - 4 N2 - BACKGROUND: Hyperhomocysteinemia is seen in most hemodialysis (HD) patients and is an independent risk factor for cardiovascular disease. Homocysteine metabolism via remethylation requires activated folate and vitamin B12 and metabolism via transsulfuration requires serine and vitamin B6. Prior studies have shown highly variable effects of supplemental B vitamin and folate therapy for hyperhomocysteinemia. We undertook a fully controlled trial with abnormally high doses of folic acid alone or with supplemental vitamin B6 and B12 compared with active folate alone or with serine. METHODS: Two prospective studies were undertaken in hemodialysis patients. In the first study (protocol A), hyperhomocysteinemia was treated in 77 patients with 30 or 60 mg folic acid with or without vitamins B6 and B12 for eight weeks and compared with matching placebos. In the second study (protocol B), hyperhomocysteinemia was treated in 37 patients with intravenous folinic acid given alone or with serine and compared with matching placebos. All patients received the standard of care treatment with a multivitamin tablet before and throughout the protocol to test the hypothesis that additional therapy is required over and above the routine therapy for maximum reduction in total homocysteine (tHcy). RESULTS: Normal volunteers; The mean (SD) tHcy of 128 normal subjects was 6.5 (4) micromol/L. Protocol A; Plasma folate increased significantly in the groups given folic acid at both four and eight weeks (P = 0.0001 at both time points). Plasma vitamin B12 was significantly increased at four weeks (P = 0.0018) but not at eight weeks (P = 0.064) in those given Vitamin B12. However, tHcy did not differ between treatment groups at baseline (P = 0.63), four weeks (P = 0.79) or eight weeks (P = 0.74). Protocol B: Plasma folate increased significantly at four weeks in those receiving folinic acid (P = 0.0001) but tHcy was not significantly different between groups (P = 0.92). In neither study was there any significant change in tHcy comparing before and during any treatment intervention. CONCLUSIONS: In our studies high dose oral folic acid, intravenous folinic acid, vitamins B6 and B12 and oral serine were ineffective at lowering tHcy in patients on hemodialysis when given folic acid, folinic acid serine or B vitamins in addition to routine folic acid and B vitamin supplements. SN - 1121-8428 UR - https://www.unboundmedicine.com/medline/citation/14696754/Controlled_trials_of_very_high_dose_folic_acid_vitamins_B12_and_B6_intravenous_folinic_acid_and_serine_for_treatment_of_hyperhomocysteinemia_in_ESRD_ L2 - https://medlineplus.gov/kidneyfailure.html DB - PRIME DP - Unbound Medicine ER -