Effects of Vitamin D Supplementation on Immune Function in Infants

Vitamin D Deficiency Clinical Trial

Official title:

Effects of Vitamin D Supplementation on Immune Function in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461665
• Other study ID #: 20150301R
• Status: Completed
• Phase: N/A
• Start date: August 18, 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: June 2020
• Source: Shih Chien University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 30, 2016
• Est. primary completion date: June 17, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 6 Months

Eligibility

Inclusion Criteria:

• Breastfeeding healthy infants

Exclusion Criteria:

• heart disease

• liver disease

• lung disease

• Intestinal disease

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Other:
• vitamin D
vitamin D supplement 10 µg daily for 2 months

Locations

Country	Name	City	State
Taiwan	Shih Chien University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Shih Chien University	Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Chawes BL, Bønnelykke 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristic of infants-1	Gender in baseline	Infants at 4 months old
Primary	Characteristic of infants-2	Gestational week (week) in baseline	Infants at 4 months old
Primary	Characteristic of infants-3	Birth length (cm) in baseline	Infants at 4 months old
Primary	Characteristic of infants-4	Birth weight (kg) in baseline	Infants at 4 months old
Primary	Characteristic of infants-5	Birth head circumference (cm) in baseline	Infants at 4 months old
Primary	Characteristic of infants-6	Exposed to the sun (min/day) in baseline	Infants at 4 months old
Primary	Characteristic of infants-7	Exclusive breast-fed n (%) in baseline	Infants at 4 months old
Primary	Characteristic of infants-8	Mixed-fed n (%) in baseline	Infants at 4 months old
Primary	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
Primary	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
Primary	Vitamin D nutritional status of infants-1	Ca (mg/dL) in both groups	Infants at 4 and 6 months old
Primary	Vitamin D nutritional status of infants-2	PTH (pg/mL) in both groups	Infants at 4 and 6 months old
Primary	Vitamin D nutritional status of infants-3	25(OH)D3 (ng/mL) in both groups	Infants at 4 and 6 months old
Secondary	Cell markers expression of B cells	D21 and CD23 expression (%) in both groups	Infants at 6 months old
Secondary	Cell markers expression of T cells	Foxp3 expression (%) in both groups	Infants at 6 months old
Secondary	Serum immunoglobulin E level of infants	Concentration of IgE (ng/ml) in both groups	Infants at 6 months old
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cytokine levels in supernatant of lymphocyte by CM-10 induction-5	Concentration of TGF-ß (pg/ml) in both groups	Lymphocyte isolation from Infants at 6 months old
Secondary	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
Secondary	Cytokine levels in supernatant of lymphocyte by LPS induction-2	Concentration of TNF-a (pg/ml) in both groups	Lymphocyte isolation from Infants at 6 months old
Secondary	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
Secondary	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
Secondary	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
Secondary	Cytokine levels in supernatant of lymphocyte by PI induction-4	Concentration of TGF-ß (pg/ml) in both groups	Lymphocyte isolation from Infants at 6 months old
Secondary	Cytokine levels in supernatant of lymphocyte by HDM induction-1	Concentration of IFN-? (pg/ml) in both groups	Lymphocyte isolation from Infants at 6 months old
Secondary	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
Secondary	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
Secondary	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
Secondary	Cytokine levels in supernatant of lymphocyte by HDM induction-5	Concentration of TGF-ß (pg/ml) in both groups	Lymphocyte isolation from Infants at 6 months old