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Vitamin D DeficiencyNCT04461665

Effects of Vitamin D Supplementation on Immune Function in Infants

A study testing vitamin D in people with Vitamin D Deficiency, run by Shih Chien University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 4 to 6 monthsHealthy volunteers can take part
Conditions the study is for
Vitamin D Deficiency
What is being tested?
vitamin D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteTaiwan
Study dates
18 Aug 2015to 30 Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Breastfeeding healthy infants

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Shih Chien University

    Taipei, 104

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
vitamin D
Keywords
vitamin D, immune, infants, breastfeeding
Medical subject headings
Vitamin D Deficiency, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vitamin DOther

    Also called Baby Ddrops® Liquid Vitamin D3 Vitamin Supplement

    vitamin D supplement 10 μg daily for 2 months

Study groups in NCT04461665
Study groupRoleWhat they receive
ControlNo interventionEnroll 6 months old breast feeding infant, who have not supplement vitamin D at pediatric clinic.
VitD supplementExperimentalEnroll 4 months old breast feeding infant, and provide 10 μg vitamin D daily for 2 months.
Receives: Other: vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characteristic of infants-1

    Gender in baseline

    Measured: Infants at 4 months old

  2. Characteristic of infants-2

    Gestational week (week) in baseline

    Measured: Infants at 4 months old

  3. Characteristic of infants-3

    Birth length (cm) in baseline

    Measured: Infants at 4 months old

  4. Characteristic of infants-4

    Birth weight (kg) in baseline

    Measured: Infants at 4 months old

  5. Characteristic of infants-5

    Birth head circumference (cm) in baseline

    Measured: Infants at 4 months old

  6. Characteristic of infants-6

    Exposed to the sun (min/day) in baseline

    Measured: Infants at 4 months old

  7. Characteristic of infants-7

    Exclusive breast-fed n (%) in baseline

    Measured: Infants at 4 months old

  8. Characteristic of infants-8

    Mixed-fed n (%) in baseline

    Measured: Infants at 4 months old

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

    Length percentile (%) in both groups

    Measured: Infants at 4 and 6 months old

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

    Weight percentile (%) in both groups

    Measured: Infants at 4 and 6 months old

  11. Vitamin D nutritional status of infants-1

    Ca (mg/dL) in both groups

    Measured: Infants at 4 and 6 months old

  12. Vitamin D nutritional status of infants-2

    PTH (pg/mL) in both groups

    Measured: Infants at 4 and 6 months old

  13. Vitamin D nutritional status of infants-3

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

    Measured: Infants at 4 and 6 months old

Secondary outcomes (19)

  1. Cell markers expression of B cells

    D21 and CD23 expression (%) in both groups

    Measured: Infants at 6 months old

  2. Cell markers expression of T cells

    Foxp3 expression (%) in both groups

    Measured: Infants at 6 months old

  3. Serum immunoglobulin E level of infants

    Concentration of IgE (ng/ml) in both groups

    Measured: Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

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

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

    Measured: Lymphocyte isolation from Infants at 6 months old

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2020
  2. Study start18 Aug 2015
  3. Primary completion17 Jun 2016
  4. Study completion30 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
4 months old or 6 months old breastfeeding infants
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04461665
Sponsor's protocol ID
20150301R
Status last verified
Jun 2020
First submitted
24 Jul 2017
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24943330

  • 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.

    PubMed 24925304

  • 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.

    PubMed 25665158

  • 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.

    PubMed 25478419

Questions about this trial

What is this clinical trial studying?

A study testing vitamin D in people with Vitamin D Deficiency, run by Shih Chien University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characteristic of infants-1 (time frame: Infants at 4 months old). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04461665, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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