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Clin Nutr. 2019 Jan 17. pii: S0261-5614(19)30008-1. doi: 10.1016/j.clnu.2019.01.006. [Epub ahead of print]

Vitamin B complex supplementation as a homocysteine-lowering therapy for early stage diabetic nephropathy in pediatric patients with type 1 diabetes: A randomized controlled trial.

Author information

1
Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt. Electronic address: nancy_elbarbary@med.asu.edu.eg.
2
Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
3
Department of Clinical Pharmacy, Faculty of Pharmacy, Ahram Canadian University, Cairo, Egypt.
4
Department of Clinical Pharmacy, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.

Abstract

BACKGROUND:

Homocysteine levels are elevated in patients with type 1 diabetes mellitus (T1DM) and could induce renal injury. B vitamins have an important role in preventing microvascular complications of diabetes.

AIM:

We performed a randomized-controlled trial of oral supplementation with vitamin B complex as an adjuvant therapy for nephropathy in pediatric T1DM patients and assessed its relation to homocysteine and cystatin C as a marker of nephropathy.

METHODS:

This trial included 80 T1DM patients with microalbuminuria, despite oral angiotensin-converting enzyme inhibitors, aged 12-18 years with at least 5 years disease duration and HbA1c ≤8.5%. Patients were randomly assigned into two groups; intervention group which received oral vitamin B complex (B1, B6 and B12) once daily and placebo group. Both groups were followed-up for 12 weeks with assessment of plasma homocysteine, HbA1c, urinary albumin excretion (UAE) and cystatin C.

RESULTS:

Both groups were well-matched in baseline clinical and laboratory parameters. Baseline homocysteine levels were elevated in both groups compared with reference control values. After 12 weeks, supplementation with vitamin B complex for the intervention group resulted in a significant decrease of homocysteine, fasting blood glucose, HbA1c, triglycerides, total cholesterol, UAE and cystatin C compared with baseline levels (p < 0.001) and with placebo group (p < 0.001). No adverse reactions were reported. Baseline cystatin C was negatively correlated to vitamin B12 (r = -0.77, p = 0.001).

CONCLUSIONS:

Vitamin B complex improved glycemic control and renal function through decreasing homocysteine and could be a safe and effective strategy for treatment of early stage nephropathy in pediatric T1DM. This trial was registered at ClinicalTrials.gov (NCT03594240).

KEYWORDS:

Cystatin C; Diabetic nephropathy; Homocysteine; Type 1 diabetes; Vitamin B complex

PMID:
30704890
DOI:
10.1016/j.clnu.2019.01.006

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