Effects of Vitamin D Supplementation on Immune Function in Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Vitamin D Supplementation on Immune Function in Infants

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Other: vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breastfeeding healthy infants Exclusion Criteria: heart disease liver disease lung disease Intestinal disease

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 months old or 6 months old breastfeeding infants
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Enroll 6 months old breast feeding infant, who have not supplement vitamin D at pediatric clinic. | |
| Experimental: VitD supplement<br>Enroll 4 months old breast feeding infant, and provide 10 μg vitamin D daily for 2 months. | Other: vitamin D<br>* vitamin D supplement 10 μg daily for 2 months<br>* Other names: Baby Ddrops® Liquid Vitamin D3 Vitamin Supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristic of infants-1 | Gender in baseline | Infants at 4 months old | 
| Characteristic of infants-2 | Gestational week (week) in baseline | Infants at 4 months old | 
| Characteristic of infants-3 | Birth length (cm) in baseline | Infants at 4 months old | 
| Characteristic of infants-4 | Birth weight (kg) in baseline | Infants at 4 months old | 
| Characteristic of infants-5 | Birth head circumference (cm) in baseline | Infants at 4 months old | 
| Characteristic of infants-6 | Exposed to the sun (min/day) in baseline | Infants at 4 months old | 
| Characteristic of infants-7 | Exclusive breast-fed n (%) in baseline | Infants at 4 months old | 
| Characteristic of infants-8 | Mixed-fed n (%) in baseline | Infants at 4 months old | 
| The anthropometric of infants from 4 months old to 6 months old-1 | Length percentile (%) in both groups | Infants at 4 and 6 months old | 
| The anthropometric of infants from 4 months old to 6 months old-2 | Weight percentile (%) in both groups | Infants at 4 and 6 months old | 
| Vitamin D nutritional status of infants-1 | Ca (mg/dL) in both groups | Infants at 4 and 6 months old | 
| Vitamin D nutritional status of infants-2 | PTH (pg/mL) in both groups | Infants at 4 and 6 months old | 
| Vitamin D nutritional status of infants-3 | 25(OH)D3 (ng/mL) in both groups | Infants at 4 and 6 months old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell markers expression of B cells | D21 and CD23 expression (%) in both groups | Infants at 6 months old | 
| Cell markers expression of T cells | Foxp3 expression (%) in both groups | Infants at 6 months old | 
| Serum immunoglobulin E level of infants | Concentration of IgE (ng/ml) in both groups | Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by CM-10 induction-1 | Concentration of IL-6 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by CM-10 induction-2 | Concentration of IL-4 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by CM-10 induction-3 | Concentration of IL-13 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by CM-10 induction-4 | Concentration of IL-10 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by CM-10 induction-5 | Concentration of TGF-β (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by LPS induction-1 | Concentration of IL-6 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by LPS induction-2 | Concentration of TNF-α (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by PI induction-1 | Concentration of IL-4 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by PI induction-2 | Concentration of IL-13 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by PI induction-3 | Concentration of IL-10 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by PI induction-4 | Concentration of TGF-β (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by HDM induction-1 | Concentration of IFN-γ (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by HDM induction-2 | Concentration of IL-4 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by HDM induction-3 | Concentration of IL-13 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by HDM induction-4 | Concentration of IL-10 (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 
| Cytokine levels in supernatant of lymphocyte by HDM induction-5 | Concentration of TGF-β (pg/ml) in both groups | Lymphocyte isolation from Infants at 6 months old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, immune, infants, breastfeeding