FindTrial
Sign In

A study to document the effect of daily supplementation with micronutrients along with iron folic acid, compared to iron folic acid alone, on cure rate from anaemia and on haemoglobin concentration, in children aged 6 to 59 months of age with mild to moderate degree of anaemia

Effect of daily therapeutic supplementation with multiple micronutrients and iron folic acid compared to iron folic acid alone in mild to moderate anemic children aged 6 to 59 months on anaemia cure and haemoglobin concentration: A randomized controlled trial in rural Haryana

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028298
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

Health Condition 1: D539- Nutritional anemia, unspecified Health Condition 2: D539- Nutritional anemia, unspecified

Interventions

Intervention1: Supplementation with multiple micronutrients along with iron folic acid: Daily supplementation for 90 days with micronutrients relevant for erythropoiesis (zinc, vitamins B1, B2, B3, B5

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, with mild to moderate anaemia 1. Children who are aged 6-59 months 2. Mild to moderate anaemia at enrolment (Hb >=7 g/dl and 3. Consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. No Anemia (Hb >=11g /dL) 2. Severe anemia (Hb 3. Documented haemoglobinopathy 4. History of repeated blood transfusions and chronic or systemic illnesses 5. Mid-upper arm circumference (MUAC) of 6. Family do not intend to stay in the study area for the duration of the intervention.

Design outcomes

Primary

MeasureTime frame
Mean haemoglobin concentration Proportion of children cured of anemia (i.e. Hb â?¥11 g/dl) Timepoint: The outcomes will be measured around a week after completion of 90 days supplementation period—

Secondary

MeasureTime frame
Cost-effective analysis of supplementing iron folic acid with multiple micronutrients compared to iron folic acid aloneTimepoint: The analysis will be conducted once the supplementation period of 90 days is over and data on outcomes are available;Laboratory parameters in a sub-sample 1. Serum ferritin (ng/ml) 2. Serum transferrin receptor (mg/l) 3. Percent transferrin saturation 4. Total iron binding capacity (mcg/dl) 5. Serum transferrin receptor to Serum ferritin ratio 6. Micronutrient (Serum Vitamin B12, Zinc and Folate) concentrations in blood and proportion deficient 7. High sensitive C-reactive protein (hs-CRP) Timepoint: The outcomes will be measured around a week after completion of 90 days supplementation period—

Countries

India

Contacts

Public ContactDr Sunita Taneja

Centre for Health Research and Development, Society for Applied Studies

ravi.upadhyay@sas.org.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026