The Association of Hormones and Peptides With Nutritional Consequences in Children With Feeding Difficulty.

NCT03045978 | Completed

• 1 other identifier: 103-7090A3
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To study the role of ghrelin, leptin, adiponectin, neuropeptide Y (NPY), orexin A, IGF-1, IGFBP-1, IGFBP-3, and corticotrophin-releasing hormone (CRH) in the nutritional status in children with feeding difficulty, and further to evaluate their regulation with feeding difficulties (anorexia, picky eating behavior, feeding disorders with concurrent medical conditions).

Conditions

Feeding Difficulty

Outcome Measures

Primary Outcomes (1)

• The change of hormones and growth factors levels in laboratory data

  Observe the level of ghrelin, leptin, adiponectin, Neuropeptide Y, orexin A, Insulin-like growth factor 1, insulin-like growth factor-binding protein 1, insulin-like growth factor-binding protein 3 and corticotropin-releasing hormone in the laboratory data.

  Changes from baseline to week 12.

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

1. Studied subjects: children with clinical diagnosis of feeding difficulty. 2. Methods of study: A total of 90 children aged 2-12 years old with feeding difficulty are enrolled into the study, and 30 healthy children are used as control. The enrolled subjects with feeding difficulty are assigned clinical survey for 12 weeks and laboratory studies at enrollment and at 12 weeks, and they are classified into 3 groups: (1) Group 1: 30 patients without malnutrition, (2) Group 2: 30 patients with mild malnutrition, and (3) Group 3: 30 patients with marked malnutrition.

You may qualify if:

• Patients with feeding difficulties are evaluated by the children gastroenterologist. The diagnosis of feeding difficulty is based on "IMFeD" program.
• Children aged 2-18 years old with feeding difficulty are enrolled.

You may not qualify if:

• pernicious anemia
• dysfunction of blood coagulation
• leukemias
• infection in skin of the blood collection sites
• edema, poor circulation or severe trauma of limb
• phlebitis or vein thrombosis

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood is collected in Serum separation tubes and kept at 4 °C for 1 before being centrifuged, and the serum is stored at -80 °C.

Study Officials

• Hsun-Chin Chao, A.P.

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: February 8, 2017
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 2, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)