Clinical trial NCT04461665: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: vitamin D, immune, infants, breastfeeding
Lead sponsor: Shih Chien University
Sponsor class: OTHER
Collaborators: name: Shin Kong Wu Ho-Su Memorial Hospital
First posted: 2020-07-08
Enrollment: 59
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 months old or 6 months old breastfeeding infants
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Breastfeeding healthy infants

Exclusion Criteria:

* heart disease
* liver disease
* lung disease
* Intestinal disease

Primary outcomes:
measure: Characteristic of infants-1
timeFrame: Infants at 4 months old
measure: Characteristic of infants-2
timeFrame: Infants at 4 months old
measure: Characteristic of infants-3
timeFrame: Infants at 4 months old
measure: Characteristic of infants-4
timeFrame: Infants at 4 months old
measure: Characteristic of infants-5
timeFrame: Infants at 4 months old
measure: Characteristic of infants-6
timeFrame: Infants at 4 months old
measure: Characteristic of infants-7
timeFrame: Infants at 4 months old
measure: Characteristic of infants-8
timeFrame: Infants at 4 months old
measure: The anthropometric of infants from 4 months old to 6 months old-1
timeFrame: Infants at 4 and 6 months old
measure: The anthropometric of infants from 4 months old to 6 months old-2
timeFrame: Infants at 4 and 6 months old
measure: Vitamin D nutritional status of infants-1
timeFrame: Infants at 4 and 6 months old
measure: Vitamin D nutritional status of infants-2
timeFrame: Infants at 4 and 6 months old
measure: Vitamin D nutritional status of infants-3
timeFrame: Infants at 4 and 6 months old
Secondary outcomes:
measure: Cell markers expression of B cells
timeFrame: Infants at 6 months old
measure: Cell markers expression of T cells
timeFrame: Infants at 6 months old
measure: Serum immunoglobulin E level of infants
timeFrame: Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by CM-10 induction-1
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by CM-10 induction-2
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by CM-10 induction-3
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by CM-10 induction-4
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by CM-10 induction-5
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by LPS induction-1
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by LPS induction-2
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by PI induction-1
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by PI induction-2
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by PI induction-3
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by PI induction-4
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by HDM induction-1
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by HDM induction-2
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by HDM induction-3
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by HDM induction-4
timeFrame: Lymphocyte isolation from Infants at 6 months old
measure: Cytokine levels in supernatant of lymphocyte by HDM induction-5
timeFrame: Lymphocyte isolation from Infants at 6 months old
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shih Chien University
Study officials:
affiliation: Shih Chien University
name: Chao-Ming Chen, MD/PHD
role: STUDY_CHAIR
References:
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.
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.
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.
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.