The Effects of Vitamin D Supplementation on Glycemic Control in Children With Type 1 Diabetes Mellitus in Gaza Strip, A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Percent of HbA1c in children with T1DM for both intervention, and control groups.
研究概览
简要总结
Type 1 diabetes mellitus (T1DM) is an immune-mediated disease characterized by diminished insulin secretion due to damage to islets of Langerhans in the pancreas, which eventually results in high levels of glucose in the blood. According to World Diabetes Foundation, in Palestine, 4.4% of diabetic patients are diagnosed with T1DM, while 95.3% are diagnosed with type 2 diabetes (T2DM) (World Diabetes Foundation, 2020).
Observational studies have reliably provided evidence that T1DM patients with acceptable glycemic control have higher 25(OH)D levels than T1DM with lesser glycemic control. Additionally, it has been specified by some of the research-based studies that there is a strong connection between the deficiency of vitamin D and the incidence of T1DM.
In interventional studies of T1DM children and adults, repletion of vitamin D in deficient individuals improved HbA1c in a period of 12 weeks. Participants were more likely to achieve HbA1c < 7.8% if they had higher 25(OH)D levels on week 12 than on baseline, especially if 25(OH)D levels were exceeded 51 nmol/l.
According to the Food and Drug Administration (FDA), The Institute of Medicine's (IOM) recommended Upper Limit (UL) for chronic Vitamin D intake for infants (children less than 1 year of age) is 25 mcg/day (1,000 IU/d), and for children age 1 year and older the recommended UL is 50 mcg/day (2,000 IU/d) (Institute of Medicine Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, 1997).
Despite a large amount of evidence from observational and experimental studies supporting the effects of vitamin D on glucose metabolism and the immune system, results from clinical studies remain inconsistent, which makes it impossible to recommend vitamin D supplementation for the treatment of T1DM. Therefore, this study aimed to investigate the status of vitamin D among T1DM children for vitamin and to examine the effects of vitamin D supplementation on glycemic control in children with T1DM. This is the first randomized controlled trial that studied the effects of vitamin D supplementation on glycemic control among T1DM children in the Gaza Strip, Palestine.
详细描述
2.1 Study design The study design was experimental, A randomized controlled trial. 2.2 Study setting The study was conducted at the endocrinology outpatients' clinic at AL-RANTISI PEDIATRIC HOSPITAL in Gaza Strip.
2.3 Study Sample After getting the ethical approval, data were collected throughout 3 months, starting from October 2017 to January 2018. In this period, 80 children who were less than 14 years old were diagnosed with T1DM which was indicated through fasting blood glucose level greater than 126 mg/dl or HbA1c cut point of ≥6.5% (American Diabetes Association, 2010), and had vitamin D deficiency which indicated by its levels of less than 12 ng/ml (Sullivan, 2019), were recruited from endocrinology outpatients' clinic at AL-RANTISI PEDIATRIC HOSPITAL in Gaza Strip.
2.4 Sampling
A stratified random sampling technique was applied to assign children with the previously mentioned criteria into two groups. The first group is the interventional (experimental) group that received vitamin D supplements (2000 IU/day) and the second group is the control group that did not receive any supplements. Both groups were on their regular diet and treatment, but one group was put on vitamin D supplement and the other group received a placebo instead. According to previous studies and after the direct supervision from the treating pediatrician and endocrinologist, the best preparation and dosage of vitamin D was used (According to FDA the recommended dose for children age 1 year and older is 2,000 IU/day). The two groups were defined as follows:
Group A: is the control group, that received a placebo as a supplement. Group B: is the interventional group that supplemented with vitamin D tablets containing 2000 IU once time daily with a meal, for 3 months of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percent of HbA1c in children with T1DM for both intervention, and control groups.
时间窗: Three Months
Change of glycemic control in children with T1DM. The glycohemoglobin levels are defined based on the control of diabetes, as good control (HbA1c\<7.8%), moderate control (HbA1c:7.8%-9.9%), and poor control (HbA1c\>9.9%). The percent of HbA1c was measured and recorded before and after the interference for both interventions, and control groups, (the interventional group was supplemented with vitamin D tablets containing 2000 IU once time daily with a meal, for 3 months of intervention). Children's health assessment structure interview sheet was used to collect data. It was constructed by the researchers based upon relevant literature. The questionnaire consisted of three parts Part I: Children's socio-demographic characteristics Part II: Children's current health history Part III: Children's laboratory investigations
次要结局
- Concentration of Vitamin D for both intervention, and control groups(Three Months)
研究者
Principal Investigator Heba Mohammed Arafat
Department of Chemical Pathology, School of Medical Sciences, Health Campus, Universiti Sains Malaysia
Al-Azhar University