Effects of Vitamin D Supplementation on Immune Function in Infants

NCT04461665 | Completed

• 1 other identifier: 20150301R
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

vitamin D, immune, infants, breastfeeding

Outcome Measures

Primary Outcomes (13)

• Characteristic of infants-1

  Gender in baseline

  Infants at 4 months old

• Characteristic of infants-2

  Gestational week (week) in baseline

  Infants at 4 months old

• Characteristic of infants-3

  Birth length (cm) in baseline

  Infants at 4 months old

• Characteristic of infants-4

  Birth weight (kg) in baseline

  Infants at 4 months old

• Characteristic of infants-5

  Birth head circumference (cm) in baseline

  Infants at 4 months old

• Characteristic of infants-6

  Exposed to the sun (min/day) in baseline

  Infants at 4 months old

• Characteristic of infants-7

  Exclusive breast-fed n (%) in baseline

  Infants at 4 months old

• Characteristic of infants-8

  Mixed-fed n (%) in baseline

  Infants at 4 months old

• 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

• 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

• Vitamin D nutritional status of infants-1

  Ca (mg/dL) in both groups

  Infants at 4 and 6 months old

• Vitamin D nutritional status of infants-2

  PTH (pg/mL) in both groups

  Infants at 4 and 6 months old

• Vitamin D nutritional status of infants-3

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

  Infants at 4 and 6 months old

Secondary Outcomes (19)

• Cell markers expression of B cells

  Infants at 6 months old

• Cell markers expression of T cells

  Infants at 6 months old

• Serum immunoglobulin E level of infants

  Infants at 6 months old

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

  Lymphocyte isolation from Infants at 6 months old

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

  Lymphocyte isolation from Infants at 6 months old

Study Arms (2)

Control

NO INTERVENTION

Enroll 6 months old breast feeding infant, who have not supplement vitamin D at pediatric clinic.

VitD supplement

EXPERIMENTAL

Enroll 4 months old breast feeding infant, and provide 10 μg vitamin D daily for 2 months.

Other: vitamin D

Interventions

vitamin D OTHER

vitamin D supplement 10 μg daily for 2 months

Also known as: Baby Ddrops® Liquid Vitamin D3 Vitamin Supplement

VitD supplement

Eligibility Criteria

• Age: 4 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Breastfeeding healthy infants

You may not qualify if:

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

Sponsors & Collaborators

• Shih Chien University: lead
• Shin Kong Wu Ho-Su Memorial Hospital: collaborator

Study Sites (1)

Shih Chien University

Taipei, 104, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 24943330 BACKGROUND

• 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.

  PMID: 24925304 BACKGROUND

• 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.

  PMID: 25665158 BACKGROUND

• 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.

  PMID: 25478419 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency; Breast Feeding

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Chao-Ming Chen, MD/PHD

  Shih Chien University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 months old or 6 months old breastfeeding infants

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 8, 2020
• Study Start: August 18, 2015
• Primary Completion: June 17, 2016
• Study Completion: December 30, 2016
• Last Updated: July 8, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)