The aim of this study is to evaluate the effectiveness of a food supplement based on Traditional Persian Medicine to improve failure to thrive of children with moderate wasting. The study is a single blind randomized clinical trial. A total of 70 children 12-18 months old with moderate wasting (weight for height Z score less than -2 and equal or greater than -3) will be enrolled. Those who have a history of congenital anomalies or any underlying diseases, will be excluded. At first, children are referred to an associated professor of pediatric gastroenterology, through health centers of Sabzevar city to visit and rule out of any other disease. Then, children randomly will be allocated into two groups. The control group will receive ferrous sulfate as 15 drops per day, Zincovit B as 5 milliliter per day in addition nutritional education. The intervention group will use the food supplement in addition to those mentioned. The intervention period will be last for 12 weeks in both groups. The main intervention of this study is a powder shape food supplement, serving as 70 grams in two meals a day in the form of porridge. Children’s weight and height will be measured every two weeks by a digital scale and a length board. The weight for height index will be calculated by using WHO Anthro Software version 3.2-2011. At the end of the study, mean chang in weight for height Z score will be compared before and after intervention between groups.
General information
Acronym
In this study does not apply
IRCT registration information
IRCT registration number:IRCT2015112125168N1
Registration date:2016-01-22, 1394/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Roghayeh Javan
Name of organization / entity
Mashhad University of Medical Sciences Faculty of Iranian Traditional Medicine and Complementary
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2188
Email address
javanr911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Mashhad
University of Medical Sciences
Expected recruitment start date
2016-01-05, 1394/10/15
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of a food supplement based on Traditional Persian Medicine to improve children Failure to Thrive
Public title
Effects of Food supplement on Failure to Thrive
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children with failure to thrive; moderate wasting; having weight for length Z score less than -2 and equal or greater than -3 according to WHO criteria; without underlying disease; age range between12-18 months
Exclusion criteria: any history of acute or chronic disease; history of congenital anomalies or genetic diseases; history of allergy and asthma ; lack of consent of parent to continue the project; having weight for length Z score less than -3; child´s absence at two consecutive follow-up time
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences Administration, Building Qureshi, Daneshgah Ave.
City
Mashhad
Postal code
91388-13944
Approval date
2015-11-07, 1394/08/16
Ethics committee reference number
IR.MUMS.REC.1394.528
Health conditions studied
1
Description of health condition studied
failure to thrive
ICD-10 code
R62.8
ICD-10 code description
Lack of Other lack of expected normal physiological development
Primary outcomes
1
Description
Weight
Timepoint
Before intervention, once every two weeks after intervention
Method of measurement
in grams, by digital scale
2
Description
Height
Timepoint
Before intervention, once every two weeks after intervention
Method of measurement
in centimeter, by length board
3
Description
weight for lenght Index
Timepoint
Before intervention, once every two weeks after intervention
Method of measurement
Zscore weight for lenght, by WHO Anthro Software version 3.2-2011
Secondary outcomes
1
Description
Side effects
Timepoint
once every two weeks
Method of measurement
Daily questionnaire filled by mothers at home
Intervention groups
1
Description
control group: ferrous sulfate drop as 15 drop per day, Zincovit B syrup as 5 milliliter per day in addition to nutritional education. Nutritional education will be given to the mother about feeding and increase the quantity and quality meals, at the beginning of the study in a session. This session lasts about 30 minutes.
Category
Treatment - Drugs
2
Description
Intervention group: ferrous sulfate drop as 15 drop per day, Zincovit B syrup as 5 milliliter per day, nutritional education to mothers and food supplement. Nutritional education will be given to the mothers about feeding and increase the quantity and quality meals at the beginning of the study. The session lasts 30 minutes. The powder form food supplement will be prepared in packages of 1000 grams, given to the mothers with a recipe once every two weeks. 70 grams of this food supplement is served in two meals a day, as porridge. The intervention period lasts for 12 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Speciality Clinic affiliated to Sabzevar University Medical Sciences
Full name of responsible person
Roghayeh Javan
Street address
Speciality Clinic affiliated to Sabzevar University Medical Sciences, Opposite the Keshavarzi Bank, Seyed Jamaloddin Asad Abadi Ave.
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences, Building Qureshi, Daneshgah Ave.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Full name of responsible person
Roghayeh Javan
Position
PhD student of Iranian Traditional Medicine and Complementary
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
+98 51 3853 5980
Email
tim@mums.ac.ir javanr911@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Yousefi
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
+98 51 3853 5980
Email
tim@mums.ac.ir YousefiM@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Full name of responsible person
Roghayeh Javan
Position
PhD student of Iranian Traditional Medicine and Complementary
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
+98 51 3853 5980
Email
javanr911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)