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临床试验/NCT01029392
NCT01029392已完成3 期

Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect on Insulin Requirements After Supplementation With Vitamin D-A Pilot Study

William Beaumont Hospitals1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
75
试验地点
1
主要终点
Change in Hemoglobin A1c

研究概览

简要总结

Our objective is to demonstrate that providing supplemental vitamin D to children with new onset DM will significantly decrease the levels of HbA1c and insulin requirement by the following methods.

  1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM).
  2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level over the past few months) and document insulin requirements before and after vitamin supplementation is given.

Hypothesis: Maintaining vitamin D levels >30 ng/ml will decrease HbA1c and insulin requirements.

详细描述

New onset type 1 DM patients who present at William Beaumont Hospital, Royal Oak or to the Pediatric Endocrine Clinic will be approached about the study at their presentation and time will be given for the patient and family to discuss and ask questions regarding the study. Patients will then be enrolled following informed consent. Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks from the point of diagnosis for 3 months (as standard practice for all newly diagnosed diabetic patients in our clinic). At the baseline visit a Vitamin D level will be drawn and frozen for 3 months prior to processing. .After 3 months vitamin D, calcium, alkaline phosphatase, phosphorus and other standard of care lab draws will be done. Approximately an additional 3 tsp of blood will be taken. All female subjects of child bearing potential will have a pregnancy test done. EMLA cream to anesthetize the area will be used prior to blood draw. A vitamin D level of <30 ng/ml is considered insufficient and the patient will then be given vitamin D supplement. The vitamin D level, calcium, alkaline phosphatase and phosphorus will be rechecked at 6 months (additional 3 tsp of blood) . Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks again for another 3 months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed type I DM.
  • Age <18 years

排除标准

  • Pregnancy

研究组 & 干预措施

Required Vitamin D

Experimental

Those children whose Vitamin D level was low (<30 ng/mL) are given Vitamin D supplementation

干预措施: Vitamin D (Drug)

结局指标

主要结局

Change in Hemoglobin A1c

时间窗: 6 months

Change in hemoglobin A1c calculated as a percentage change from baseline measurement

次要结局

  • Change in Insulin Requirements(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Gerrits, MD

Principal Investigator

William Beaumont Hospitals

研究点 (1)

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