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A study to to assess the effect of weekly iron, folic acid and Vit B12 (IFAB)supplementation among 6-24 months children on reduction in anaemia prevalence

Weekly iron, folate and vitamin B12 (IFAB) supplementation in children between 6-24 months: A cluster randomized trial from Wardha - None

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/12/005270
Enrollment
2121
Registered
2014-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: IFAB weekly group, IFA weekly group : IFAB weekly group will receive 20mg elemental Iron, 300ug Folic Acid and 1.8ug Vitamin B12 once a week for 12 months
IFA weekly group will receive 20mg elemental Iron and 300ug Folic Acid once a week for 12 months Control Intervention1: IFA daily group: This group will receive 20mg elemental Iron and 100ug Folic Ac

Sponsors

Department of Biotechnology New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: o All children who are 6-24 months o Parent residing in any of the anganwadi area and intends to remain in the area o Apparently healthy o Receiving complementary food in addition to breast milk o Willingness to participate and follow up for 1 year after recruitment into the study

Exclusion criteria

Exclusion criteria: o Children whose Hb levels at registration are o Children falling under â??Pinkâ?? category as per IMNCI guidelines o Complicated SAM: SAM with any one of the following namely anorexia, high fever ( >104 F), severe pallor, severe dehydration, lower respiratory tract infection, bipedal edema, visible severe wasting o Participantâ??s parents not able, available or willing to accept weekly follow up by study staff. o Any condition in the parents/participant which in the judgement of investigator, would interfere with or serve as a contradiction to protocol adherence or a participantsâ?? parentsâ?? inability to give informed consent.

Design outcomes

Primary

MeasureTime frame
Difference in percentage change of anaemia prevalence after one year of supplementation in IFA weekly and IFAB weekly arm Difference in percentage change of anaemia prevalence after one year of supplementation in IFA weekly and IFA daily armTimepoint: Beginning of study and end of one year of supplementation

Secondary

MeasureTime frame
Cost of intervention per one DALY averted due to reduction in prevalence of anaemiaTimepoint: Beginning of study and end of one year of supplementation;Difference in mean change in haemoglobin after one year of supplementation in IFA weekly arm and IFA daily arm; difference in change in weight for height / height for age / weight for age Z scores after one year of supplementation in IFA weekly arm and IFA daily armTimepoint: Beginning of study and end of one year of supplementation ;Difference in mean change in haemoglobin in IFA weekly arm and IFAB weekly arm; difference in change in weight for height / height for age / weight for age Z scores after one year of supplementation in IFA weekly arm and IFAB weekly armTimepoint: Beginning of study and end of one year of supplementation;Difference in rate of occurrence of adverse events related to supplementation in all three armsTimepoint: Beginning of study and end of one year of supplementation

Countries

India

Contacts

Public ContactHemant Deepak Shewade

MGIMS Sevagram

hemantjipmer@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026