| 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
|
|
|
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
|
|
|
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. |