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Completed

NCT Number: NCT04461665

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Behavior Breast Feeding Deficiency Diseases Feeding Behavior Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

4 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shih Chien University

Taipei, 104, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Breastfeeding healthy infants

Exclusion criteria

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

Treatment and study plan

Vitamin D

Other

vitamin D supplement 10 μg daily for 2 months

Other names: Baby Ddrops® Liquid Vitamin D3 Vitamin Supplement

Primary outcomes

  1. Characteristic of infants-1

    Time frame: Infants at 4 months old

    Gender in baseline

  2. Characteristic of infants-2

    Time frame: Infants at 4 months old

    Gestational week (week) in baseline

  3. Characteristic of infants-3

    Time frame: Infants at 4 months old

    Birth length (cm) in baseline

  4. Characteristic of infants-4

    Time frame: Infants at 4 months old

    Birth weight (kg) in baseline

  5. Characteristic of infants-5

    Time frame: Infants at 4 months old

    Birth head circumference (cm) in baseline

  6. Characteristic of infants-6

    Time frame: Infants at 4 months old

    Exposed to the sun (min/day) in baseline

  7. Characteristic of infants-7

    Time frame: Infants at 4 months old

    Exclusive breast-fed n (%) in baseline

  8. Characteristic of infants-8

    Time frame: Infants at 4 months old

    Mixed-fed n (%) in baseline

  9. The anthropometric of infants from 4 months old to 6 months old-1

    Time frame: Infants at 4 and 6 months old

    Length percentile (%) in both groups

  10. The anthropometric of infants from 4 months old to 6 months old-2

    Time frame: Infants at 4 and 6 months old

    Weight percentile (%) in both groups

  11. Vitamin D nutritional status of infants-1

    Time frame: Infants at 4 and 6 months old

    Ca (mg/dL) in both groups

  12. Vitamin D nutritional status of infants-2

    Time frame: Infants at 4 and 6 months old

    PTH (pg/mL) in both groups

  13. Vitamin D nutritional status of infants-3

    Time frame: Infants at 4 and 6 months old

    25(OH)D3 (ng/mL) in both groups

Secondary outcomes

  1. Cell markers expression of B cells

    Time frame: Infants at 6 months old

    D21 and CD23 expression (%) in both groups

  2. Cell markers expression of T cells

    Time frame: Infants at 6 months old

    Foxp3 expression (%) in both groups

  3. Serum immunoglobulin E level of infants

    Time frame: Infants at 6 months old

    Concentration of IgE (ng/ml) in both groups

  4. Cytokine levels in supernatant of lymphocyte by CM-10 induction-1

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-6 (pg/ml) in both groups

  5. Cytokine levels in supernatant of lymphocyte by CM-10 induction-2

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-4 (pg/ml) in both groups

  6. Cytokine levels in supernatant of lymphocyte by CM-10 induction-3

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-13 (pg/ml) in both groups

  7. Cytokine levels in supernatant of lymphocyte by CM-10 induction-4

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-10 (pg/ml) in both groups

  8. Cytokine levels in supernatant of lymphocyte by CM-10 induction-5

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of TGF-β (pg/ml) in both groups

  9. Cytokine levels in supernatant of lymphocyte by LPS induction-1

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-6 (pg/ml) in both groups

  10. Cytokine levels in supernatant of lymphocyte by LPS induction-2

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of TNF-α (pg/ml) in both groups

  11. Cytokine levels in supernatant of lymphocyte by PI induction-1

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-4 (pg/ml) in both groups

  12. Cytokine levels in supernatant of lymphocyte by PI induction-2

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-13 (pg/ml) in both groups

  13. Cytokine levels in supernatant of lymphocyte by PI induction-3

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-10 (pg/ml) in both groups

  14. Cytokine levels in supernatant of lymphocyte by PI induction-4

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of TGF-β (pg/ml) in both groups

  15. Cytokine levels in supernatant of lymphocyte by HDM induction-1

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IFN-γ (pg/ml) in both groups

  16. Cytokine levels in supernatant of lymphocyte by HDM induction-2

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-4 (pg/ml) in both groups

  17. Cytokine levels in supernatant of lymphocyte by HDM induction-3

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-13 (pg/ml) in both groups

  18. Cytokine levels in supernatant of lymphocyte by HDM induction-4

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of IL-10 (pg/ml) in both groups

  19. Cytokine levels in supernatant of lymphocyte by HDM induction-5

    Time frame: Lymphocyte isolation from Infants at 6 months old

    Concentration of TGF-β (pg/ml) in both groups

Sponsors and collaborators

Lead sponsor

Shih Chien University

Other

Collaborators

  • Shin Kong Wu Ho-Su Memorial Hospital

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 8, 2020
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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