Effects of Vitamin D Supplementation on Immune Function in Infants

Shih Chien University

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Other: vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT04461665

20150301R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 4 to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Breastfeeding healthy infants

Exclusion criteria

• heart disease
• liver disease
• lung disease
• Intestinal disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Control

No Intervention group

Description:

Enroll 6 months old breast feeding infant, who have not supplement vitamin D at pediatric clinic.

VitD supplement

Experimental group

Description:

Enroll 4 months old breast feeding infant, and provide 10 μg vitamin D daily for 2 months.

Treatment:

Other: vitamin D