Effects of Vitamin D Supplementation on Immune Function in Infants

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Other: vitamin D

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 104
    • Shih Chien University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Breastfeeding healthy infants

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shih Chien University
• Collaborators: Shin Kong Wu Ho-Su Memorial Hospital
• Investigators: Study Chair: Chao-Ming Chen, MD/PHD, Shih Chien University

Publications and helpful links

General Publications

• Vasiliou JE, Lui S, Walker SA, Chohan V, Xystrakis E, Bush A, Hawrylowicz CM, Saglani S, Lloyd CM. Vitamin D deficiency induces Th2 skewing and eosinophilia in neonatal allergic airways disease. Allergy. 2014 Oct;69(10):1380-9. doi: 10.1111/all.12465. Epub 2014 Aug 4.
• Chawes BL, Bonnelykke K, Jensen PF, Schoos AM, Heickendorff L, Bisgaard H. Cord blood 25(OH)-vitamin D deficiency and childhood asthma, allergy and eczema: the COPSAC2000 birth cohort study. PLoS One. 2014 Jun 12;9(6):e99856. doi: 10.1371/journal.pone.0099856. eCollection 2014.
• Dawodu A, Davidson B, Woo JG, Peng YM, Ruiz-Palacios GM, de Lourdes Guerrero M, Morrow AL. Sun exposure and vitamin D supplementation in relation to vitamin D status of breastfeeding mothers and infants in the global exploration of human milk study. Nutrients. 2015 Feb 5;7(2):1081-93. doi: 10.3390/nu7021081.
• Somashekar AR, Prithvi AB, Gowda MN. Vitamin d levels in children with bronchial asthma. J Clin Diagn Res. 2014 Oct;8(10):PC04-7. doi: 10.7860/JCDR/2014/10387.5055. Epub 2014 Oct 20.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2015
• Primary Completion (Actual): June 17, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: vitamin D, immune, infants, breastfeeding
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 20150301R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No