| CTRI Number |
CTRI/2025/02/080226 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Iron Fortified Dark Chocolate] |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Standard treatment and Iron-Folic acid Fortified dark chocolate on Iron deficiency anemia in school children |
|
Scientific Title of Study
|
Effect of standard treatment for Iron deficiency anemia over effects of fortified dark chocolate with iron and folic acid among school children
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indhumathi RK |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Community Medicine, Saveetha Medical College and Hospital, Thandalam, Chennai, Tamil nadu, India.
Department of Community Medicine, Saveetha Medical College and Hospital, Thandalam, Chennai, Tamil nadu, India.
Chennai
TAMIL NADU
602105
India |
| Phone |
9789277797 |
| Fax |
|
| Email |
rkindhumathi01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Buvnesh Kumar M |
| Designation |
Professor, Department of community medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Community Medicine, Saveetha Medical College and Hospital, Thandalam, Chennai, Tamil nadu, India.
Department of Community Medicine, Saveetha Medical College and Hospital, Thandalam, Chennai, Tamil nadu, India.
Chennai
TAMIL NADU
602105
India |
| Phone |
9176899784 |
| Fax |
|
| Email |
buvnesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indhumathi RK |
| Designation |
Postgraduate, Department of community medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Community Medicine, Saveetha Medical College and Hospital, Thandalam, Chennai, Tamil nadu, India.
Department of Community Medicine, Saveetha Medical College and Hospital, Thandalam, Chennai, Tamil nadu, India.
Chennai
TAMIL NADU
602105
India |
| Phone |
9789277797 |
| Fax |
|
| Email |
rkindhumathi01@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Indhumathi RK |
Saveetha institute of medical and technical sciences |
Department of community medicine/ Saveetha hospital/ Ward 120-123
Chennai
TAMIL NADU |
9789277797
rkindhumathi01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IRON AND FOLIC ACID TABLETS |
Standard treatment for Iron deficiency anemia WHO Guidelines |
| Intervention |
Iron fortified dark chocolate |
To assess the efficacy of fortified dark chocolate for increasing the level of haemoglobin, and to improve micronutrient status and is sustainable once established |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1)â Age- 12 to 17 years school children
2)â Children with mild to moderate anaemia
|
|
| ExclusionCriteria |
| Details |
1)Blood haemoglobin less than 8g/dl.
2)Patient having occult blood positive on stool examination.
3)Any other type of anemia except Iron Deficiency Anemia (IDA).
4)IDA with any associated severe complication |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of fortified dark chocolate for increasing the level of haemoglobin and anemia status |
Baseline/3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The efficacy of fortified dark chocolate for improving anaemia status and to improve micronutrient status |
Baseline/3months |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
 Iron deficiency (ID), the primary cause of anemia, has adverse effects on both human health and socioeconomic development, with increased susceptibility to infections, elevated risk of maternal and child mortality, impaired cognitive and physical development of children, and lower work productivity of adults .The 2011 estimates suggest anemia affects around 800 million children and women worldwide. Anemia is primarily caused by iron deficiency but also by other micronutrient deficiencies such as vitamins B2, folate, and B12. Iron deficiency during the school years can impair physical and mental development and reduce school attendance by increasing morbidity. Some studies reported that it is still possible to improve cognition at school age by improving iron status , as well as positive effects on morbidity and growth, but the overall effects on these outcomes were equivocal and more evidence is required from studies in different contexts. Food fortification is an effective and cost effective, medium-term approach to improve micronutrient status and is sustainable once established. Since the prevalence of micronutrient deficiencies are generally higher and the consequences are graver in children, the identification of a child friendly vehicle is important. |