Effects of Vitamin D Supplementation on Immune Function in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Characteristic of infants-6
研究概览
简要总结
Current study shows that vitamin D deficiency might affect human's immune function. Although breast milk is the best food of infants, however the vitamin D content in breast milk is low. Thus, breastfeeding infants are at high risk of vitamin D deficiency.Children's development and health are always the most important issues for parents. However, high prevalence of allergy in infants in Taiwan were not only with environmental factor which may also relate to their nutritional status. The aim of this study was to enroll breastfeeding infant at age of 4 month, and provide vitamin D supplement 10 μg daily until 6 month, to discuss the effects of vitamin D supplementation on immune function in infants.
详细描述
Study plan to enroll breastfeeding infant at age of 4 month, and provide vitamin D (vitD) supplement 10 μg daily until 6 month. we also enroll 6 month-old infant as control group.
All infants collected 5 ml artery blood and measured vitD nutritional status and immune function. Blood analysis contain complete blood count (CBC), differential count (DC), serum calcium, serum Parathyroid hormone (PTH), serum 25(OH)D3, serum total immunoglobulinE (IgE) and cell phagocytosis.
Peripheral blood mononuclear cell (PBMC) in blood was separated and cultured with complete medium contain 10% fetal bovine serum (CM10), or with different mitogens, include lipopolysaccharide (LPS), phorbol 12-myristate 13-acetate and ionomycin (PI) and house dust mite extract (HDM). PBMC are incubated at 37 ℃, 5% CO2 for 48 hours, and determined the expression of B cell with IgE receptor CD21 and CD23 and T regulatory cell with transcription factor Foxp3 by flow cytometry. All data were analyzed with SPSS 20.0. Infant sex and feeding type were analyzed by chi-square analysis. Difference between vitD supplement group and control group were analyzed by student's t test. Relationship between 25(OH)D3 and Calcium or PTH were analyzed by pearson correlation analysis. There was a significant difference when p-value was less than 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Breastfeeding healthy infants
排除标准
- •heart disease
- •liver disease
- •lung disease
- •Intestinal disease
结局指标
主要结局
Characteristic of infants-6
时间窗: Infants at 4 months old
Exposed to the sun (min/day) in baseline
The anthropometric of infants from 4 months old to 6 months old-2
时间窗: Infants at 4 and 6 months old
Weight percentile (%) in both groups
Characteristic of infants-5
时间窗: Infants at 4 months old
Birth head circumference (cm) in baseline
Vitamin D nutritional status of infants-2
时间窗: Infants at 4 and 6 months old
PTH (pg/mL) in both groups
Characteristic of infants-1
时间窗: Infants at 4 months old
Gender in baseline
Characteristic of infants-4
时间窗: Infants at 4 months old
Birth weight (kg) in baseline
Characteristic of infants-8
时间窗: Infants at 4 months old
Mixed-fed n (%) in baseline
Vitamin D nutritional status of infants-1
时间窗: Infants at 4 and 6 months old
Ca (mg/dL) in both groups
Characteristic of infants-2
时间窗: Infants at 4 months old
Gestational week (week) in baseline
Characteristic of infants-3
时间窗: Infants at 4 months old
Birth length (cm) in baseline
Vitamin D nutritional status of infants-3
时间窗: Infants at 4 and 6 months old
25(OH)D3 (ng/mL) in both groups
Characteristic of infants-7
时间窗: Infants at 4 months old
Exclusive breast-fed n (%) in baseline
The anthropometric of infants from 4 months old to 6 months old-1
时间窗: Infants at 4 and 6 months old
Length percentile (%) in both groups
次要结局
- Serum immunoglobulin E level of infants(Infants at 6 months old)
- Cell markers expression of B cells(Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by LPS induction-1(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by PI induction-1(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by PI induction-4(Lymphocyte isolation from Infants at 6 months old)
- Cell markers expression of T cells(Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by CM-10 induction-5(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by HDM induction-3(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by HDM induction-4(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by CM-10 induction-1(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by CM-10 induction-2(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by LPS induction-2(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by PI induction-2(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by PI induction-3(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by HDM induction-1(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by HDM induction-5(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by CM-10 induction-3(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by CM-10 induction-4(Lymphocyte isolation from Infants at 6 months old)
- Cytokine levels in supernatant of lymphocyte by HDM induction-2(Lymphocyte isolation from Infants at 6 months old)