This study is a randomized double blind trial that evaluates effect of Cyproheptadine on weight gain in underweight children. Inclusion criteria include: all children aged 2 to 10 years with a weight below the 50th percentile. Exclusion criteria include: children with underlying organic condition causing growth failure. The sample size was calculated 68 and the study population was children aged 2-10 years with growth failure that referred to gastroenterology clinic at Mousavi Hospital in Zanjan. The patients randomly were divided into two groups. Nutrition education will be reformed into both groups. The first group was given Cyproheptadine syrup with dose 0.1 mg/kg/dose TDS orally for 2 months and the second group was given Placebo with dose 0.1 mg/kg/dose TDS orally for 2 months. The children were assessed every month up to 2 months and the response to treatment (especially weight gain) and adverse effects recorded. All children are re-evaluated two months after cessation of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101318971N3
Registration date:2014-10-15, 1393/07/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-15, 1393/07/23
Registrant information
Name
Kambiz Eftekhari
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7301 3000
Email address
k-eftekhari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
The research department of Zanjan University of Medical Sciences.
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cyproheptadine on weight gain in underweight children ages 2-10 years old.
Public title
Effect of Cyproheptadine on weight gain in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include: all children aged 2 to 10 years with a weight below the 50th percentile; Children whose parents have given consent to participate in the study.
Exclusion criteria include: children with underlying organic condition (gastrointestinal, cardiovascular, respiratory, renal and nervous systems) causing growth failure; inappropriate use of medicines; discourage children from study; did not return for follow-up; occurs severe disease and side effects of medication.
Age
From 2 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Science
Street address
Zanjan
City
Zanjan
Postal code
4513956183
Approval date
2014-08-23, 1393/06/01
Ethics committee reference number
ZUMS.REC.1393.104
Health conditions studied
1
Description of health condition studied
Growth retardation
ICD-10 code
R64
ICD-10 code description
Cachexia
Primary outcomes
1
Description
Weight gain
Timepoint
Every month up to 2 months, 2 months after treatment
Method of measurement
Weighing the patient
Secondary outcomes
1
Description
Increase Height
Timepoint
Every month up to 2 months, 2 months after treatment
Method of measurement
height measurements
2
Description
Side Effects and complication
Timepoint
Every month up to 2 months, 2 months after treatment
Method of measurement
History and physical examination
Intervention groups
1
Description
The first group was given Cyproheptadine syrup with dose 0.1 mg/kg/dose TDS orally for 2 months.
Category
Treatment - Drugs
2
Description
The second group was given Placebo with dose 0.1 mg/kg/dose TDS orally for 2 months.