Effects of Vitamin D Supplementation on Immune Function in Infants
NCT ID: NCT04461665
Last Updated: 2020-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2015-08-18
2016-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Enroll 6 months old breast feeding infant, who have not supplement vitamin D at pediatric clinic.
No interventions assigned to this group
VitD supplement
Enroll 4 months old breast feeding infant, and provide 10 μg vitamin D daily for 2 months.
vitamin D
vitamin D supplement 10 μg daily for 2 months
Interventions
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vitamin D
vitamin D supplement 10 μg daily for 2 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* liver disease
* lung disease
* Intestinal disease
4 Months
6 Months
ALL
Yes
Sponsors
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Shin Kong Wu Ho-Su Memorial Hospital
OTHER
Shih Chien University
OTHER
Responsible Party
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Principal Investigators
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Chao-Ming Chen, MD/PHD
Role: STUDY_CHAIR
Shih Chien University
Locations
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Shih Chien University
Taipei, , Taiwan
Countries
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References
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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.
Other Identifiers
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20150301R
Identifier Type: -
Identifier Source: org_study_id
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