Comparison of response to standard treatment plus therapeutic vitamin D dose, with standard treatment and maintenance vitamin D in children with functional constipation, randomized clinical trial
The aim of this study is evaluation of supplemental vitamin D effect in management of functional constipation in children. Patients suffer from functional constipation and low serum level of vitamin D randomized to receive standard treatment protocol of constipation with or without vitamin D. Their therapeutic response will be evaluate and compare in 4, 8 weeks and 3 months in both groups.
Design
The patients will be randomized with block method to 1- standard regimen for constipation therapy 2- standard regimen plus vitamin D therapy
Settings and conduct
patients are selected from clients to Valiasr hospital with complaint of constipation without any red flag aged 1-18 years and vitamin D deficiency.They are randomized to two intervention (constipation therapy and therapeutic dose of vitamin D)and control (constipation therapy and maintenance dose of vitamin D)groups. Their response to treatment are assessed and compared at 4 and 8 weeks and third months.
Participants/Inclusion and exclusion criteria
Any patient aged 1-18 years old with functional constipation and vitamin D deficiency is included and any patient with red flags such as low age,FTT, abnormal physical exam, history of abdominal surgery is excluded
Intervention groups
The standard therapeutic protocol vs standard with therapeutic dose of vitamin D
Main outcome variables
Therapeutic response is evaluated based on fecal frequency and consistency, fecal incontinence ,abdominal pain and difficulty in defecation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121107011392N3
Registration date:2020-10-20, 1399/07/29
Registration timing:prospective
Last update:2020-10-20, 1399/07/29
Update count:0
Registration date
2020-10-20, 1399/07/29
Registrant information
Name
Masoumeh Asgarshirazi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1596
Email address
m_shirazi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of response to standard treatment plus therapeutic vitamin D dose, with standard treatment and maintenance vitamin D in children with functional constipation, randomized clinical trial
Public title
Comparison of response to standard treatment plus therapeutic vitamin D dose, with standard treatment and maintenance vitamin D in children with functional constipation, randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Any patient with functional constipation aged 1-18 years old
Exclusion criteria:
Any red flag such as patient's age less than 1 yr,FTT,abdominal distention, enterocolitis history or any abnormal finding in examination, history of constipation therapy in last 4 wks, mental retardation, hypothyroidism, celiac disease, cystic fibrosis or hx of abdominal surgery .
Age
From 1 year old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study constipated patients with vitamin D deficiency have been divided in two intervention and control groups based on block randomization based on intervention and control groups(A,B) two allele block no 4:AA BB/AB AB/
BA BA/BB AA/BA AB/AB BA
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients and their parents don't know the role of supplemental vit D in constipation treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of children medical center,Tehran University of Medical Sciences
Street address
Gharib Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2020-08-27, 1399/06/06
Ethics committee reference number
IR.TUMS.CHMC.REC.1399.106
Health conditions studied
1
Description of health condition studied
functional constipation
ICD-10 code
K59.0
ICD-10 code description
K59.0
2
Description of health condition studied
Functional constipation based on ROME IV criteria
ICD-10 code
K59.0
ICD-10 code description
K59.0
Primary outcomes
1
Description
Therapeutic responce
Timepoint
4 and 8 weeks and 3 months after therapy
Method of measurement
Check list for fecal frequency and consistancy
Secondary outcomes
1
Description
Complication as abdominal pain, nausea and vomiting and fecal incontinence
Timepoint
4 and 8 weeks and 3 months after therapy
Method of measurement
Check list and question
Intervention groups
1
Description
Those that receive standard constipation treatment plus therapeutic dose of vitamin D