Vitamin D Deficiency
Conditions
Keywords
vitamin D, immune, infants, breastfeeding
Brief summary
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.
Detailed description
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.
Interventions
OTHERvitamin D
vitamin D supplement 10 μg daily for 2 months
Sponsors
Shin Kong Wu Ho-Su Memorial Hospital
Shih Chien University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
4 months old or 6 months old breastfeeding infants
Eligibility
Sex/Gender
ALL
Age
4 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* Breastfeeding healthy infants
Exclusion criteria
* heart disease * liver disease * lung disease * Intestinal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristic of infants-1 | Infants at 4 months old | Gender in baseline |
| Characteristic of infants-2 | Infants at 4 months old | Gestational week (week) in baseline |
| Characteristic of infants-3 | Infants at 4 months old | Birth length (cm) in baseline |
| Characteristic of infants-4 | Infants at 4 months old | Birth weight (kg) in baseline |
| Characteristic of infants-5 | Infants at 4 months old | Birth head circumference (cm) in baseline |
| Characteristic of infants-6 | Infants at 4 months old | Exposed to the sun (min/day) in baseline |
| Characteristic of infants-7 | Infants at 4 months old | Exclusive breast-fed n (%) in baseline |
| Characteristic of infants-8 | Infants at 4 months old | Mixed-fed n (%) in baseline |
| The anthropometric of infants from 4 months old to 6 months old-1 | Infants at 4 and 6 months old | Length percentile (%) in both groups |
| The anthropometric of infants from 4 months old to 6 months old-2 | Infants at 4 and 6 months old | Weight percentile (%) in both groups |
| Vitamin D nutritional status of infants-1 | Infants at 4 and 6 months old | Ca (mg/dL) in both groups |
| Vitamin D nutritional status of infants-2 | Infants at 4 and 6 months old | PTH (pg/mL) in both groups |
| Vitamin D nutritional status of infants-3 | Infants at 4 and 6 months old | 25(OH)D3 (ng/mL) in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cytokine levels in supernatant of lymphocyte by PI induction-4 | Lymphocyte isolation from Infants at 6 months old | Concentration of TGF-β (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by HDM induction-1 | Lymphocyte isolation from Infants at 6 months old | Concentration of IFN-γ (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by HDM induction-2 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-4 (pg/ml) in both groups |
| Cell markers expression of B cells | Infants at 6 months old | D21 and CD23 expression (%) in both groups |
| Cytokine levels in supernatant of lymphocyte by HDM induction-4 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-10 (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by HDM induction-5 | Lymphocyte isolation from Infants at 6 months old | Concentration of TGF-β (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by HDM induction-3 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-13 (pg/ml) in both groups |
| Cell markers expression of T cells | Infants at 6 months old | Foxp3 expression (%) in both groups |
| Serum immunoglobulin E level of infants | Infants at 6 months old | Concentration of IgE (ng/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by CM-10 induction-1 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-6 (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by CM-10 induction-2 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-4 (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by CM-10 induction-3 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-13 (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by CM-10 induction-4 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-10 (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by CM-10 induction-5 | Lymphocyte isolation from Infants at 6 months old | Concentration of TGF-β (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by LPS induction-1 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-6 (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by LPS induction-2 | Lymphocyte isolation from Infants at 6 months old | Concentration of TNF-α (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by PI induction-1 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-4 (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by PI induction-2 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-13 (pg/ml) in both groups |
| Cytokine levels in supernatant of lymphocyte by PI induction-3 | Lymphocyte isolation from Infants at 6 months old | Concentration of IL-10 (pg/ml) in both groups |
Countries
Taiwan
Outcome results
None listed