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Effects of Vitamin D Supplementation on Immune Function in Infants

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
vitamin D
Sponsored by
Shih Chien University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring vitamin D, immune, infants, breastfeeding

Eligibility Criteria

4 Months - 6 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Breastfeeding healthy infants

Exclusion Criteria:

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

Sites / Locations

  • Shih Chien University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

VitD supplement

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 24, 2017
Last Updated
July 1, 2020
Sponsor
Shih Chien University
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04461665
Brief Title
Effects of Vitamin D Supplementation on Immune Function in Infants
Official Title
Effects of Vitamin D Supplementation on Immune Function in Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 18, 2015 (Actual)
Primary Completion Date
June 17, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shih Chien University
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
vitamin D, immune, infants, breastfeeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 months old or 6 months old breastfeeding infants
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Enroll 6 months old breast feeding infant, who have not supplement vitamin D at pediatric clinic.
Arm Title
VitD supplement
Arm Type
Experimental
Arm Description
Enroll 4 months old breast feeding infant, and provide 10 μg vitamin D daily for 2 months.
Intervention Type
Other
Intervention Name(s)
vitamin D
Other Intervention Name(s)
Baby Ddrops® Liquid Vitamin D3 Vitamin Supplement
Intervention Description
vitamin D supplement 10 μg daily for 2 months
Primary Outcome Measure Information:
Title
Characteristic of infants-1
Description
Gender in baseline
Time Frame
Infants at 4 months old
Title
Characteristic of infants-2
Description
Gestational week (week) in baseline
Time Frame
Infants at 4 months old
Title
Characteristic of infants-3
Description
Birth length (cm) in baseline
Time Frame
Infants at 4 months old
Title
Characteristic of infants-4
Description
Birth weight (kg) in baseline
Time Frame
Infants at 4 months old
Title
Characteristic of infants-5
Description
Birth head circumference (cm) in baseline
Time Frame
Infants at 4 months old
Title
Characteristic of infants-6
Description
Exposed to the sun (min/day) in baseline
Time Frame
Infants at 4 months old
Title
Characteristic of infants-7
Description
Exclusive breast-fed n (%) in baseline
Time Frame
Infants at 4 months old
Title
Characteristic of infants-8
Description
Mixed-fed n (%) in baseline
Time Frame
Infants at 4 months old
Title
The anthropometric of infants from 4 months old to 6 months old-1
Description
Length percentile (%) in both groups
Time Frame
Infants at 4 and 6 months old
Title
The anthropometric of infants from 4 months old to 6 months old-2
Description
Weight percentile (%) in both groups
Time Frame
Infants at 4 and 6 months old
Title
Vitamin D nutritional status of infants-1
Description
Ca (mg/dL) in both groups
Time Frame
Infants at 4 and 6 months old
Title
Vitamin D nutritional status of infants-2
Description
PTH (pg/mL) in both groups
Time Frame
Infants at 4 and 6 months old
Title
Vitamin D nutritional status of infants-3
Description
25(OH)D3 (ng/mL) in both groups
Time Frame
Infants at 4 and 6 months old
Secondary Outcome Measure Information:
Title
Cell markers expression of B cells
Description
D21 and CD23 expression (%) in both groups
Time Frame
Infants at 6 months old
Title
Cell markers expression of T cells
Description
Foxp3 expression (%) in both groups
Time Frame
Infants at 6 months old
Title
Serum immunoglobulin E level of infants
Description
Concentration of IgE (ng/ml) in both groups
Time Frame
Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by CM-10 induction-1
Description
Concentration of IL-6 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by CM-10 induction-2
Description
Concentration of IL-4 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by CM-10 induction-3
Description
Concentration of IL-13 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by CM-10 induction-4
Description
Concentration of IL-10 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by CM-10 induction-5
Description
Concentration of TGF-β (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by LPS induction-1
Description
Concentration of IL-6 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by LPS induction-2
Description
Concentration of TNF-α (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by PI induction-1
Description
Concentration of IL-4 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by PI induction-2
Description
Concentration of IL-13 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by PI induction-3
Description
Concentration of IL-10 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by PI induction-4
Description
Concentration of TGF-β (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by HDM induction-1
Description
Concentration of IFN-γ (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by HDM induction-2
Description
Concentration of IL-4 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by HDM induction-3
Description
Concentration of IL-13 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by HDM induction-4
Description
Concentration of IL-10 (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old
Title
Cytokine levels in supernatant of lymphocyte by HDM induction-5
Description
Concentration of TGF-β (pg/ml) in both groups
Time Frame
Lymphocyte isolation from Infants at 6 months old

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Breastfeeding healthy infants Exclusion Criteria: heart disease liver disease lung disease Intestinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao-Ming Chen, MD/PHD
Organizational Affiliation
Shih Chien University
Official's Role
Study Chair
Facility Information:
Facility Name
Shih Chien University
City
Taipei
ZIP/Postal Code
104
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24943330
Citation
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.
Results Reference
background
PubMed Identifier
24925304
Citation
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.
Results Reference
background
PubMed Identifier
25665158
Citation
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.
Results Reference
background
PubMed Identifier
25478419
Citation
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.
Results Reference
result

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Effects of Vitamin D Supplementation on Immune Function in Infants

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