Is Vitamin D Deficiency Linked to Functional Constipation In Children

October 23, 2024 updated by: Amany Mohammed El-Rebigi, MD, Benha University

Constipation is one of the most common causes of patient visits to pediatric clinics. Prevalence of constipation is estimated between 1.9-27.2% in the USA (Rasquin et al., 2006).

In children aged <18 years, its prevalence was about 0.7-29.6%. Untreated constipation may cause fecal impaction and fecal soiling5 which are seen in about 1-3% of children (Bulloch and Tenenbein, 2002).

Constipation may cause gastrointestinal problems such as abdominal pain, anal pruritus, rectal bleeding, and anorexia or non-gastrointestinal complications such as urinary problems (Dehghani et al., 2015).

Functional constipation is defined as constipation without an organic etiology and is diagnosed according to the Rome criteria1-3. The symptom- based Rome criteria were first developed for adults in 1989 during a consensus meeting of experts in the field of functional gastrointestinal disorders. These criteria have been updated several times and are now internationally acknowledged and used for both research and clinical purposes. The revised Rome IV criteria- for childhood and adult functional constipation were published in 2016 (Benninga et al., 2016), (Hyams et al., 2016), (Lacy et al., 2016).

Functional constipation, a common disorder in all age groups, shows some similarities in children and adults, but important differences exist regarding epidemiology, symptomatology, pathophysiology, diagnostic workup and therapeutic management. In this research, we hypothesized that serum vitamin D deficiency could be associated with chronic functional constipation in children secondary to delayed transit intestinal time and consequently we will investigate this relationship and the related psychological aspects.

Study Overview

Status

Active, not recruiting

Detailed Description

In this research, we hypothesized that serum vitamin D deficiency could be associated with chronic functional constipation in children secondary to delayed transit intestinal time and consequently we will investigate this relationship and the related psychological aspects.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Al-Qalyubia
      • Banhā, Al-Qalyubia, Egypt, 13511
        • Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All pediatric patients who were diagnosed with chronic functional constipation according to Revised Rome IV criteria included in this study will be subjected to:

  • Demographic data upon admission including age, sex, weight, length, BMI, level of education of parents & residency.
  • The following data will be collected from patients with chronic constipation: Nutritional history, frequency of defecation per day, history of painful or hard bowel movements, history of excessive stool retention, history of large diameter stools, presence of a large fecal mass in the rectum, history of fecal incontinence per week, history of large diameter stools that can obstruct the toilet, duration of the disease and treatment.
  • Clinical data including symptoms as constipation, abdominal pain and swelling and signs like abdominal distension.

Diagnosis of Functional chronic constipation in pediatric was done according to the Revised Rome IV criteria

Description

Inclusion Criteria:

- All pediatric Patients from 6 to 16 years old who were diagnosed with chronic constipation in gastrointestinal and hepatology clinic, at Benha university Hospital according to revised Rome IV criteria will be consecutively recruited in this study.

Sex- and age-matched approximate-health children will be recruited as a control group.

Exclusion Criteria:

  • 1)- Age < 6 years and > 16 years old. 2)- Children with any chronic medical disease. 3)- Children who receive any medications. 4)- Children with organic causes of constipation such as anal fissure, stenosis or stricture, inflammatory bowel disease and intestinal malabsorption.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D level in Children with functional constipation
Time Frame: 6 months
Investigate the relationship between serum 25-hydroxyvitamin D levels and functional chronic constipation in children.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amany M. El-Rebigi, PhD, MD, lecturer of pediatric and neonatology, Faculty of medicine, Benha University
  • Principal Investigator: Rasha M. Zakaria, PhD, MD, lecturer of pediatric and neonatology, Faculty of medicine, Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Functional Constipation in Children

Subscribe