Iron Deficiency AnemiaNCT07919327
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
An observational study of Iron Deficiency Anemia and Parenting Intervention, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
The goal of this observational follow-up study is to learn about the long-term effects of early childhood parenting interventions and iron supplementation on young adults in rural Bangladesh. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iron Deficiency Anemia, Parenting Intervention
- How many people
- 379 participants
- Where
- 1 siteBangladesh
- Study dates
- 2 Sep 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: The study population will comprise young adults aged approximately 20-21 years who participated in a previously completed cluster randomized controlled trial conducted in 30 villages in rural Bangladesh. The original trial enrolled children aged 6-24 months, including iron-deficient anemic and non-anemic children, who were assigned to early childhood parenting intervention or no parenting intervention; anemic children received iron supplementation. Approximately 19 years after the original trial, eligible surviving participants who can be traced will be invited to participate in the follow-up study. Immediate adolescent siblings of the original participants aged above 15 years will also be invited to assess potential spillover effects of the early childhood parenting intervention.
Who may be able to join
- Individuals who participated in the endline assessment of the original study.
- Individuals who can be successfully located and contacted during this 19-year follow-up period.
- Individuals who provide written informed consent to participate in the study.
Who cannot join
- Individuals who cannot be traced or contacted despite repeated attempts.
- Individuals who did not participate in the endline assessment of the original study.
- Individuals who decline or withdraw informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Long-term Impacts of Early Childhood Psychosocial Stimulation and Iron Supplementation on IQ, Mental Health, and Behavior in Young Adulthood: 19-year Follow-up of a cRCT
The goal of this observational follow-up study is to learn about the long-term effects of early childhood parenting interventions and iron supplementation on young adults in rural Bangladesh. The main questions it aims to answer are:
Do early psychosocial stimulation interventions and iron supplementations lead to sustained improvements in IQ, reduction in mental health and violent behavior into young adulthood?
Read more
Does the psychosocial parenting stimulation intervention generate "trickle-down" effects on younger siblings within the same families?
Participants from a previously completed cluster randomized controlled trial conducted in 30 villages in Bangladesh will be invited to participate at approximately 19 years after the original intervention. Young adults aged 20-21 years will undergo assessments of IQ, depressive symptoms, violent behavior, social support-seeking capacity, and hand grip strength. Younger siblings will also be assessed for selected outcomes to examine potential spillover effects of the original parenting intervention.
- Conditions
- Iron Deficiency Anemia, Parenting Intervention
- Keywords
- Early childhood, Parenting, Psychosocial Stimulation, Iron, IQ, Mental Health, Behavior, Young Adulthood
- Medical subject headings
- Anemia, Iron-Deficiency, Psychological Well-Being, Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Intelligence Quotient (IQ) in Young Adulthood
IQ will be assessed using the Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II). The overall IQ score will be used to evaluate the long-term effects of early childhood psychosocial stimulation and iron supplementation on cognitive functioning in young adulthood.
Measured: At the 19-year follow-up assessment, when participants are approximately 20-21 years of age.
Secondary outcomes (5)
Depressive Symptoms in Young Adulthood
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). For adolescent siblings, depressive symptoms will be assessed using the Patient Health Questionnaire for Adolescents (PHQ-A). Scores will be used to characterize depressive symptom severity.
Measured: At the 19-year follow-up assessment; participants will be approximately 20-21 years old.
Violent Behavior Traits in Young Adulthood
Violent behavior will be assessed using the Bangla-adapted Buss-Perry Aggression Questionnaire (BPAQ). Questionnaire scores will be used to characterize aggression-related behavior and examine the long-term effects of the original interventions.
Measured: At the 19-year follow-up assessment, when original trial participants are approximately 20-21 years of age.
Perceived Social Support
Social support will be assessed using the Oslo Social Support Scale. The resulting score will be used to characterize the perceived social support of the participants.
Measured: At the 19-year follow-up assessment, when original trial participants are approximately 20-21 years of age.
Hand Grip Strength in Young Adulthood
Hand grip strength will be measured using a dynamometer following Southampton protocols. Measurements will be used to characterize participants' physical strength.
Measured: At the 19-year follow-up assessment, when original trial participants are approximately 20-21 years of age.
Depressive Symptoms and Aggressive Behaviors Among Adolescent Siblings
Depressive symptoms and aggressive behaviors among participants' immediate adolescent siblings aged above 12 years will be assessed using the Patient Health Questionnaire for Adolescents (PHQ-A) and the Bangla-adapted Buss-Perry Aggression Questionnaire (BPAQ), respectively. Outcomes will be examined according to the original parenting intervention exposure to evaluate potential trickle-down effects of the early childhood intervention.
Measured: At the 19-year follow-up assessment, among eligible immediate adolescent siblings aged above 15 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start2 Sep 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 379 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheikh Jamal Hossain, Ph.D, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919327
- Sponsor's protocol ID
- PR-26-047
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share our data to international collaborator. They will help us in manuscript writing only.
Publications
Kocalevent RD, Berg L, Beutel ME, Hinz A, Zenger M, Harter M, Nater U, Brahler E. Social support in the general population: standardization of the Oslo social support scale (OSSS-3). BMC Psychol. 2018 Jul 17;6(1):31. doi: 10.1186/s40359-018-0249-9.
PubMed 30016997Sayer AA, Kirkwood TB. Grip strength and mortality: a biomarker of ageing? Lancet. 2015 Jul 18;386(9990):226-7. doi: 10.1016/S0140-6736(14)62349-7. Epub 2015 May 13. No abstract available.
PubMed 25982159Ortega FB, Silventoinen K, Tynelius P, Rasmussen F. Muscular strength in male adolescents and premature death: cohort study of one million participants. BMJ. 2012 Nov 20;345:e7279. doi: 10.1136/bmj.e7279.
PubMed 23169869Johnson JG, Harris ES, Spitzer RL, Williams JB. The patient health questionnaire for adolescents: validation of an instrument for the assessment of mental disorders among adolescent primary care patients. J Adolesc Health. 2002 Mar;30(3):196-204. doi: 10.1016/s1054-139x(01)00333-0.
PubMed 11869927Rahman MA, Dhira TA, Sarker AR, Mehareen J. Validity and reliability of the Patient Health Questionnaire scale (PHQ-9) among university students of Bangladesh. PLoS One. 2022 Jun 8;17(6):e0269634. doi: 10.1371/journal.pone.0269634. eCollection 2022.
PubMed 35675375Williams N. PHQ-9. Occup Med (Lond). 2014 Mar;64(2):139-40. doi: 10.1093/occmed/kqt154. No abstract available.
PubMed 24562689Tofail F, Hamadani JD, Mehrin F, Ridout DA, Huda SN, Grantham-McGregor SM. Psychosocial stimulation benefits development in nonanemic children but not in anemic, iron-deficient children. J Nutr. 2013 Jun;143(6):885-93. doi: 10.3945/jn.112.160473. Epub 2013 Apr 24.
PubMed 23616511Grantham-McGregor SM, Powell CA, Walker SP, Himes JH. Nutritional supplementation, psychosocial stimulation, and mental development of stunted children: the Jamaican Study. Lancet. 1991 Jul 6;338(8758):1-5. doi: 10.1016/0140-6736(91)90001-6.
PubMed 1676083Waber DP, Vuori-Christiansen L, Ortiz N, Clement JR, Christiansen NE, Mora JO, Reed RB, Herrera MG. Nutritional supplementation, maternal education, and cognitive development of infants at risk of malnutrition. Am J Clin Nutr. 1981 Apr;34(Suppl 4):807-13. doi: 10.1093/ajcn/34.4.807.
PubMed 7223696Vazir S, Engle P, Balakrishna N, Griffiths PL, Johnson SL, Creed-Kanashiro H, Fernandez Rao S, Shroff MR, Bentley ME. Cluster-randomized trial on complementary and responsive feeding education to caregivers found improved dietary intake, growth and development among rural Indian toddlers. Matern Child Nutr. 2013 Jan;9(1):99-117. doi: 10.1111/j.1740-8709.2012.00413.x. Epub 2012 May 24.
PubMed 22625182Pitchik HO, Tofail F, Rahman M, Akter F, Sultana J, Shoab AK, Huda TMN, Jahir T, Amin MR, Hossain MK, Das JB, Chung EO, Byrd KA, Yeasmin F, Kwong LH, Forsyth JE, Mridha MK, Winch PJ, Luby SP, Fernald LC. A holistic approach to promoting early child development: a cluster randomised trial of a group-based, multicomponent intervention in rural Bangladesh. BMJ Glob Health. 2021 Mar;6(3):e004307. doi: 10.1136/bmjgh-2020-004307.
PubMed 33727278Low MS, Speedy J, Styles CE, De-Regil LM, Pasricha SR. Daily iron supplementation for improving anaemia, iron status and health in menstruating women. Cochrane Database Syst Rev. 2016 Apr 18;4(4):CD009747. doi: 10.1002/14651858.CD009747.pub2.
PubMed 27087396Lozoff B, Jimenez E, Smith JB. Double burden of iron deficiency in infancy and low socioeconomic status: a longitudinal analysis of cognitive test scores to age 19 years. Arch Pediatr Adolesc Med. 2006 Nov;160(11):1108-13. doi: 10.1001/archpedi.160.11.1108.
PubMed 17088512Falkingham M, Abdelhamid A, Curtis P, Fairweather-Tait S, Dye L, Hooper L. The effects of oral iron supplementation on cognition in older children and adults: a systematic review and meta-analysis. Nutr J. 2010 Jan 25;9:4. doi: 10.1186/1475-2891-9-4.
PubMed 20100340Pasricha SR, Hayes E, Kalumba K, Biggs BA. Effect of daily iron supplementation on health in children aged 4-23 months: a systematic review and meta-analysis of randomised controlled trials. Lancet Glob Health. 2013 Aug;1(2):e77-e86. doi: 10.1016/S2214-109X(13)70046-9. Epub 2013 Jul 24.
PubMed 25104162
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Impacts of Early Childhood Psychosocial Stimulation and Iron Supplementation on IQ, Mental Health, and Behavior in Young Adulthood: 19-year Follow-up of a cRCT
- ClinicalTrials.gov ID
- NCT07919327
- Acronym / sponsor ID
- PR-26-047
- Conditions
- Iron Deficiency Anemia, Parenting Intervention
- Keywords
- Early childhood, Parenting, Psychosocial Stimulation, Iron, IQ, Mental Health, Behavior, Young Adulthood
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 379 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational follow-up study is to learn about the long-term effects of early childhood parenting interventions and iron supplementation on young adults in rural Bangladesh. The main questions it aims to answer are:
Do early psychosocial stimulation interventions and iron supplementations lead to sustained improvements in IQ, reduction in mental health and violent behavior into young adulthood?
Does the psychosocial parenting stimulation intervention generate "trickle-down" effects on younger siblings within the same families?
Participants from a previously completed cluster randomized controlled trial conducted in 30 villages in Bangladesh will be invited to participate at approximately 19 years after the original intervention. Young adults aged 20-21 years will undergo assessments of IQ, depressive symptoms, violent behavior, social support-seeking capacity, and hand grip strength. Younger siblings will also be assessed for selected outcomes to examine potential spillover effects of the original parenting intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comprise young adults aged approximately 20-21 years who participated in a previously completed cluster randomized controlled trial conducted in 30 villages in rural Bangladesh. The original trial enrolled children aged 6-24 months, including iron-deficient anemic and non-anemic children, who were assigned to early childhood parenting intervention or no parenting intervention; anemic children received iron supplementation. Approximately 19 years after the original trial, eligible surviving participants who can be traced will be invited to participate in the follow-up study. Immediate adolescent siblings of the original participants aged above 15 years will also be invited to assess potential spillover effects of the early childhood parenting intervention.
Key inclusion criteria (3 listed)
- Individuals who participated in the endline assessment of the original study.
- Individuals who can be successfully located and contacted during this 19-year follow-up period.
- Individuals who provide written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Individuals who cannot be traced or contacted despite repeated attempts.
- Individuals who did not participate in the endline assessment of the original study.
- Individuals who decline or withdraw informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intelligence Quotient (IQ) in Young Adulthood
Time frame: At the 19-year follow-up assessment, when participants are approximately 20-21 years of age.
IQ will be assessed using the Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II). The overall IQ score will be used to evaluate the long-term effects of early childhood psychosocial stimulation and iron supplementation on cognitive functioning in young adulthood.
5 secondary outcomes
Depressive Symptoms in Young Adulthood
Time frame: At the 19-year follow-up assessment; participants will be approximately 20-21 years old.
Violent Behavior Traits in Young Adulthood
Time frame: At the 19-year follow-up assessment, when original trial participants are approximately 20-21 years of age.
Perceived Social Support
Time frame: At the 19-year follow-up assessment, when original trial participants are approximately 20-21 years of age.
Hand Grip Strength in Young Adulthood
Time frame: At the 19-year follow-up assessment, when original trial participants are approximately 20-21 years of age.
Depressive Symptoms and Aggressive Behaviors Among Adolescent Siblings
Time frame: At the 19-year follow-up assessment, among eligible immediate adolescent siblings aged above 15 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 30016997Kocalevent RD, Berg L, Beutel ME, Hinz A, Zenger M, Harter M, Nater U, Brahler E. Social support in the general population: standardization of the Oslo social support scale (OSSS-3). BMC Psychol. 2018 Jul 17;6(1):31. doi: 10.1186/s40359-018-0249-9.
- Background: PubMed 25982159Sayer AA, Kirkwood TB. Grip strength and mortality: a biomarker of ageing? Lancet. 2015 Jul 18;386(9990):226-7. doi: 10.1016/S0140-6736(14)62349-7. Epub 2015 May 13. No abstract available.
- Background: PubMed 23169869Ortega FB, Silventoinen K, Tynelius P, Rasmussen F. Muscular strength in male adolescents and premature death: cohort study of one million participants. BMJ. 2012 Nov 20;345:e7279. doi: 10.1136/bmj.e7279.
- Background: PubMed 11869927Johnson JG, Harris ES, Spitzer RL, Williams JB. The patient health questionnaire for adolescents: validation of an instrument for the assessment of mental disorders among adolescent primary care patients. J Adolesc Health. 2002 Mar;30(3):196-204. doi: 10.1016/s1054-139x(01)00333-0.
- Background: PubMed 35675375Rahman MA, Dhira TA, Sarker AR, Mehareen J. Validity and reliability of the Patient Health Questionnaire scale (PHQ-9) among university students of Bangladesh. PLoS One. 2022 Jun 8;17(6):e0269634. doi: 10.1371/journal.pone.0269634. eCollection 2022.
- Background: PubMed 24562689Williams N. PHQ-9. Occup Med (Lond). 2014 Mar;64(2):139-40. doi: 10.1093/occmed/kqt154. No abstract available.
- Background: PubMed 23616511Tofail F, Hamadani JD, Mehrin F, Ridout DA, Huda SN, Grantham-McGregor SM. Psychosocial stimulation benefits development in nonanemic children but not in anemic, iron-deficient children. J Nutr. 2013 Jun;143(6):885-93. doi: 10.3945/jn.112.160473. Epub 2013 Apr 24.
- Background: PubMed 1676083Grantham-McGregor SM, Powell CA, Walker SP, Himes JH. Nutritional supplementation, psychosocial stimulation, and mental development of stunted children: the Jamaican Study. Lancet. 1991 Jul 6;338(8758):1-5. doi: 10.1016/0140-6736(91)90001-6.
- Background: PubMed 7223696Waber DP, Vuori-Christiansen L, Ortiz N, Clement JR, Christiansen NE, Mora JO, Reed RB, Herrera MG. Nutritional supplementation, maternal education, and cognitive development of infants at risk of malnutrition. Am J Clin Nutr. 1981 Apr;34(Suppl 4):807-13. doi: 10.1093/ajcn/34.4.807.
- Background: PubMed 22625182Vazir S, Engle P, Balakrishna N, Griffiths PL, Johnson SL, Creed-Kanashiro H, Fernandez Rao S, Shroff MR, Bentley ME. Cluster-randomized trial on complementary and responsive feeding education to caregivers found improved dietary intake, growth and development among rural Indian toddlers. Matern Child Nutr. 2013 Jan;9(1):99-117. doi: 10.1111/j.1740-8709.2012.00413.x. Epub 2012 May 24.
- Background: PubMed 33727278Pitchik HO, Tofail F, Rahman M, Akter F, Sultana J, Shoab AK, Huda TMN, Jahir T, Amin MR, Hossain MK, Das JB, Chung EO, Byrd KA, Yeasmin F, Kwong LH, Forsyth JE, Mridha MK, Winch PJ, Luby SP, Fernald LC. A holistic approach to promoting early child development: a cluster randomised trial of a group-based, multicomponent intervention in rural Bangladesh. BMJ Glob Health. 2021 Mar;6(3):e004307. doi: 10.1136/bmjgh-2020-004307.
- Background: PubMed 27087396Low MS, Speedy J, Styles CE, De-Regil LM, Pasricha SR. Daily iron supplementation for improving anaemia, iron status and health in menstruating women. Cochrane Database Syst Rev. 2016 Apr 18;4(4):CD009747. doi: 10.1002/14651858.CD009747.pub2.
- Individual participant dataSharing planned: No. We will not share our data to international collaborator. They will help us in manuscript writing only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheikh Jamal Hossain, Ph.D principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia and Parenting Intervention, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intelligence Quotient (IQ) in Young Adulthood (time frame: At the 19-year follow-up assessment, when participants are approximately 20-21 years of age.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07919327, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.