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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Active Comparator | Intervention group included pediatric patients with diabetic nephropathy receiving oral vitamin B complex tablets( Neurorubine TM -Forte Lactab TM ) once daily. |
|
| Control group | Placebo Comparator | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) | Drug | Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma homocysteine | Change in plasma homocysteine level after 12 weeks of oral vitamin B complex intake | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c level | Change in HbA1c level after 12 weeks of oral vitamin B complex intake | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Patients were excluded if they have any of the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nancy Elbarbary | Cairo | 11361 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30704890 | Derived | Elbarbary NS, Ismail EAR, Zaki MA, Darwish YW, Ibrahim MZ, El-Hamamsy M. 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. Clin Nutr. 2020 Jan;39(1):49-56. doi: 10.1016/j.clnu.2019.01.006. Epub 2019 Jan 17. |
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Mainly clinical characteristics
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| ID | Term |
|---|---|
| D014803 | Vitamin B Complex |
| ID | Term |
|---|---|
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Patients were randomly assigned into two groups; intervention group who received vitamin B complex once daily orally and control group who did not receive B complex
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| Placebo | Dietary Supplement | Patients in placebo group 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. |
|
| D020164 |
| Chemical Actions and Uses |