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CTRI Number  CTRI/2025/10/095607 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 03/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Sleep Pattern In Infants With Iron Deficiency At 12 Months Of Age 
Scientific Title of Study   Sleep Pattern In Infants With Iron Deficiency At 12 Months Of Age: A One Year Cross Sectional Study At Tertiary Hospital 
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 YS NAND KISHORE GOUD  
Designation  Paediatric Junior Resident  
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road Belagavi Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9247800947  
Fax    
Email  drnkg9999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ROOPA M BELLAD 
Designation  Professor in Paediatrics  
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road Belagavi Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9448113403  
Fax    
Email  roopabellad11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr YS NAND KISHORE GOUD  
Designation  Paediatric Junior Resident  
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road Belagavi Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9247800947  
Fax    
Email  drnkg9999@gmail.com  
 
Source of Monetary or Material Support  
KLEs Dr Prabhakar Kore Hospital, Jawaharlal Nehru MEDICAL COLLEGE, Nehru Nagar Belagavi 
 
Primary Sponsor  
Name  Dr YS NAND KISHORE GOUD  
Address  Department of Paediatrics, Jawaharlal Nehru Medical College, KLE University Belagavi, Karnataka, India, 590010.  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr YS NAND KISHORE GOUD  KLEs DR PRABHAKAR KORE HOSPITAL BELAGAVI  Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road Belgaum, Karnataka, Belgaum, KARNATAKA.
Belgaum
KARNATAKA 
9247800947

drnkg9999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E611||Iron deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  11.00 Month(s)
Age To  13.00 Month(s)
Gender  Both 
Details  1 Infants at 12 months of age
2 Haemoglobin less than 12 microgram per deciliter
3 Iron indices namely
Serum ferritin less than 12 microgram per liter
Serum iron less than 23 microgram per liter
Total iron binding capacity less than 434 microgram per deciliter
Iron saturation less than 20 percent
4 Parents who gave concent for study
 
 
ExclusionCriteria 
Details  1 Diagnosed case of iron deficiency on treatment
2 History of blood transfusion
3 Children with acute illness  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sleep pattern in the first year of life in relation to iron deficiency  Over a span of one year 
 
Secondary Outcome  
Outcome  TimePoints 
Corelation between haemoglobin and serum ferritin levels and sleep parameters  Over a span of one year 
 
Target Sample Size   Total Sample Size="117"
Sample Size from India="117" 
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)   20/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Anemia, defined as a hemoglobin concentration lower than the normal range for a child’s age and is a significant global health issue. Anemia was defined as a hemoglobin level below 11 g/dl(1). Anemia commonly affects children aged 6 to 59 months, with an estimated global prevalence of 39.8%, translating to approximately 269 million children(2). This condition is particularly prevalent in early infancy and childhood, where rapid growth increases iron requirements.
          According to the national family health survey (NFHS-5), the prevalence of anemia among Indian children has risen from 58.6% (NFHS-4) to 67.1% nationally, with 53.5% in rural Karnataka and 66.3% in Belagavi district(3).
          Iron deficiency, which accounts for approximately 50% of all anemia cases in children(2), is known to adversely affect growth, cognitive development, immunity, and overall well-being. A growing body of evidence suggests that Iron Deficiency may also negatively impact sleep quality and sleep architecture in infants, although this area remains under-explored(2).
          Iron Deficiency in early life can impair brain development, delay neural maturation, and affect neurotransmitter metabolism, all of which may influence sleep regulation. Additionally, Iron plays a key role in the synthesis of dopamine and melatonin—neurochemicals integral to the regulation of sleep-wake cycles,(4) Iron deficiency, even in the absence of anemia, may cause sleep disturbances such as increased night waking, restlessness, and reduced sleep duration. These disruptions may further impair the neurodevelopmental trajectory of affected infants. Anemia had significantly shorter sleep duration compared to their non-anemic peers. The presence of anemia increased the odds of being a short sleeper by over four times.
          Infants diagnosed with iron deficiency anemia (ida) have been observed to experience changes in sleep structure, more frequent night awakenings, and decreased quiet sleep compared to those without anemia. Recent studies highlight that these sleep disruptions—such as reduced total sleep time, increased night time waking, and altered sleep architecture—can affect not just the infant’s immediate well-being but also their long-term neurological development. Nonetheless, these studies come with several limitations, including small sample sizes, reliance on sleep data reported by caregivers, absence of extended follow-up, and a focus on non-indian populations, which limits the applicability of findings to the indian setting.
          In the Indian context, despite the high prevalence of Iron Deficiency among young children, there is a noticeable lack of research examining how iron deficiency affects infant sleep—particularly around 11 to 13 months of age, a crucial period for both brain development and the establishment of regular sleep patterns. This study aims to bridge that gap by investigating the impact of Iron Deficiency on sleep among Indian infants. The scarcity of region-specific data reinforces the importance of this research. The first year of life is a key stage for brain development, and many indian infants are affected by Iron Deficiency during this time. Disrupted sleep in infancy could have lasting consequences for behavior and cognitive development. Addressing Iron Deficiency early through iron supplementation might help enhance both sleep quality and overall developmental progress. Additionally, it is important to raise awareness among healthcare providers regarding the potential sleep-related issues linked to ida, which are often overlooked. This research seeks to deepen the understanding of how iron deficiency may contribute to sleep disturbances in infants and to support the development of timely interventions.
 
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