The Role of Vitamin B Complex as an Adjuvant Therapy for Diabetic Nephropathy in Pediatric Patients With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in plasma homocysteine
研究概览
简要总结
Homocysteine levels have been found elevated in T1DM patients with Diabetic nephropathy (DN) due to several causes, including dietary deficiencies. Hyperhomocysteinemia induces renal injury and is associated with increasing urinary albumin excretion(UAE). Therefore, the investigators performed a randomized-controlled trial of oral supplementation with vitamin B complex as an adjuvant therapy for nephropathy in pediatric patients with T1DM and assessed its relation to homocysteine levels, glycemic control, microalbuminuria and cystatin C as a marker of nephropathy.
详细描述
This trial included 80 vitamin B12-deficient T1DM patients with nephropathy, despite oral angiotensin-converting enzyme inhibitors . Enrolled patients aged 12-18 years with at least 5 years disease duration and HbA1c ≤8.5%. Patients were randomly assigned into two groups; intervention group who received vitamin B complex once daily orally . The other group did not receive any supplementation and served as a control group. Both groups were followed-up for 12 weeks with assessment of plasma homocysteine, HbA1c, cystatin C and UAE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes.
- •Patients aged 12-18 years with at least 5 years disease duration.
- •Active diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion [UAE] 30-299 mg/g creatinine in two of three samples over a 3- to 6- months period despite angiotensin converting enzyme inhibitors)
- •Hemoglobin A1c (HbA1c) ≤8.5%
- •Patients on regular visit to clinic.
- •Patients on regular insulin therapy.
排除标准
- •Patients were excluded if they have any of the following:
- •Patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes.
- •Patients with any evidence of renal impairment due to cause other than diabetes.
- •Patients with hypertension.
- •Hepatitis virus infection (B or C) or any evidence of infection.
- •Taking any vitamins or food supplements one month before study.
- •Participation in a previous investigational drug study within 3 months preceding screening.
研究组 & 干预措施
intervention group
Intervention group included pediatric patients with diabetic nephropathy receiving oral vitamin B complex tablets( Neurorubine TM -Forte Lactab TM ) once daily.
干预措施: Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) (Drug)
Control group
Placebo group or control patients received placebo that were similar in appearance to vitamin B complex tablets and the administered dose was as the same schedule as vitamin B complex .
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in plasma homocysteine
时间窗: 12 weeks
Change in plasma homocysteine level after 12 weeks of oral vitamin B complex intake
次要结局
- Change in HbA1c level(12 weeks)
研究者
Nancy Samir Elbarbary
Professor of Pediatrics
Ain Shams University