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

Not yet recruiting

• Conditions: Nutritional anemia, unspecified, (2) ICD-10 Condition: D539||Nutritional anemia, unspecified,

• Registration Number: CTRI/2020/10/028298
• Lead Sponsor: Centre for Health Research and Development Society for Applied Studies

Brief Summary

The proposed individually randomized open label trial aims to evaluate the effect of daily supplementation, for 90 days, of erythropoiesis-relevant micronutrients (zinc, vitamins B1, B3, B5, B2, B12, B6, A, C, E and D) in addition to iron folic acid (IFA) in comparison with IFA alone, in children aged 6 to 59 monthswith mild to moderate anaemia, on anaemia cure rate and haemoglobin concentration. Other outcomes (secondary outcomes) will be assessed in a sub-sample of study children and include serum ferritin, serum transferrin receptor, total iron binding capacity, percent transferrin saturation, micronutrient levels and levels of inflammatory markers (hs-CRP). We also propose to perform a cost effectiveness analysis.Micronutrient (Serum Vitamin B12, Zinc and Folate) levels in blood and proportion deficient, serum hepcidin and hs-CRP will be assessed in a randomly selected sub-sample of children at baseline. The study question emerged from a national consultation facilitated by the Indian Council of Medical Research (ICMR), an apex body in India for formulation, coordination and promotion of biomedical research, because of the growing concern of the national government that the rate of decline in burden of childhood anemia is quite slow.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-07-10
• Study Start: 2020-10-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 1300

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 <11g/dl) 3.
• Consent to participate in the study.

Exclusion Criteria

• No Anemia (Hb ≥11g /dL) 2.
• Severe anemia (Hb <7g/dL) 3.
• Documented haemoglobinopathy 4.
• History of repeated blood transfusions and chronic or systemic illnesses 5.
• Mid-upper arm circumference (MUAC) of <11.5cm 6.
• Family do not intend to stay in the study area for the duration of the intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean haemoglobin concentration	The outcomes will be measured around a week after completion of 90 days supplementation period
Proportion of children cured of anemia (i.e. Hb ≥11 g/dl)	The outcomes will be measured around a week after completion of 90 days supplementation period

Secondary Outcome Measures

Name	Time	Method
Laboratory parameters in a sub-sample	1. Serum ferritin (ng/ml)
Cost-effective analysis of supplementing iron folic acid with multiple micronutrients compared to iron folic acid alone	The analysis will be conducted once the supplementation period of 90 days is over and data on outcomes are available

Trial Locations

Locations (1)

Centre for Health Research and Development, Society for Applied Studies; 🇮🇳 Faridabad, HARYANA, India

Centre for Health Research and Development, Society for Applied Studies

🇮🇳Faridabad, HARYANA, India

Dr Ravi Prakash Upadhyay

Principal investigator

011-46043751

ravi.upadhyay@sas.org.in