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A study to understand the effect of providing micronutrients along with iron folic acid, compared to iron folic acid alone, on haemoglobin level and anaemia prevalence in 6 to 59 months old children

Effect of biweekly preventive supplementation with multiple micronutrients and iron folic acid compared to iron folic acid alone in children aged 6 to 59 months on haemoglobin concentration and anaemia prevalence: A randomized controlled trial in rural Haryana - None

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028299
Enrollment
1300
Registered
2020-10-08
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: Micronutrients supplementation along with iron folic acid: Biweekly supplementation with micronutrients (zinc, vitamins B1, B2, B3, B5, B6, B12, A, C, E and D) along with iron folic aci

Sponsors

Centre for Health Research and Development Society for Applied Studies
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6-59 months, residing in rural areas of Palwal district, irrespective of their anaemia status at enrolment. Children in whom the consent for participation is available from primary caregiver(s) will be eligible for inclusion

Exclusion criteria

Exclusion criteria: 1. Documented haemoglobinopathy 2. Documented history of repeated blood transfusions 3. Documented chronic or systemic illnesses 4. Mid-upper arm circumference (MUAC) of 5. Severe palmar pallor 6. Family members planning to move away from the study area.

Design outcomes

Primary

MeasureTime frame
Mean hemoglobin concentration Proportion of children with anemia Timepoint: 51 weeks (up to plus/minus 2 weeks)—

Secondary

MeasureTime frame
Cost-effective analysis of supplementing iron folic acid with multiple micronutrients compared to iron folic acid aloneTimepoint: 51 weeks (up to plus/minus 2 weeks);Laboratory parameters in a sub-sample Serum ferritin (ng/ml) Serum transferrin receptor (mg/l) Percent transferrin saturation Total iron binding capacity (mcg/dl) Serum transferrin receptor to Serum ferritin ratio Micronutrient (Serum Vitamin B12, Zinc and Folate) concentrations in blood and proportion deficient High sensitive C-reactive protein (hs-CRP) and alpha-1 acid glycoprotein (AGP) Timepoint: 51 weeks (up to plus/minus 2 weeks)—

Countries

India

Contacts

Public ContactDr Sunita Taneja

Centre for Health Research and Development, Society for Applied Studies

ravi.upadhyay@sas.org.in011-46043751-55

Outcome results

None listed

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