A study to compare different daily doses of iron and folic acid supplements for improving anaemia among adolescent girls in Telangana

Relative Efficacy of Different Doses of Iron (45mg, 60mg, and 120mg) Along with Folic Acid (500mcg) Supplementation in Improving Iron Status and Long-term Effects Among Adolescent Girls: A Randomized Controlled Trial in Mahbubnagar, Telangana - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104218

Enrollment

450

Registered

2026-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

Intervention1: Low-dose Iron + Folic Acid supplementation: Low-dose Iron + Folic Acid supplementation Intervention2: Moderate-dose Iron + Folic Acid supplementation: Participants will receive oral sup

Eligibility

Inclusion criteria

Inclusion criteria: Female adolescents aged 12 to 19 years Mild to moderate anaemia is defined as hemoglobin 8.0 11.4 g per dL at baseline Resident of selected government residential hostels Residing in the hostel for at least 6 months before enrolment Likely to remain in the hostel for the duration of the intervention and follow-up Willing to participate and provide written informed consent greater than or equal to 18 years) or parental consent with adolescent assent (less than 18 years

Exclusion criteria

Exclusion criteria: Severe anaemia (hemoglobin less than 8.0 g per dL) requiring immediate medical treatment Known hemoglobinopathies (e.g., sickle cell disease, thalassemia) Chronic inflammatory or systemic illnesses Disorders affecting iron absorption Current or recent (within the last 3 months) iron supplementation or anaemia treatment Known hypersensitivity to iron or folic acid Pregnant or lactating adolescents Any condition that, in the opinion of the investigator, may interfere with study participation

Design outcomes

Primary

Measure	Time frame
Mean change in hemoglobin concentration (g per dL)Timepoint: base line to 90 days	—

Secondary

Measure	Time frame
Change in iron status biomarkers (serum ferritin, transferrin saturation, soluble transferrin receptor, serum hepcidin)Timepoint: Baseline, 90 days, and 365 days;Proportion of participants achieving hemoglobin greater than 12.0 g per dLTimepoint: 90 days and 365 days;Frequency and severity of gastrointestinal adverse effects (nausea, vomiting, constipation, diarrhea)Timepoint: During the 90-day intervention period;Association between menstrual blood loss (PBAC score) and hemoglobin responseTimepoint: Baseline and 90 days	—

Measure

Time frame

Change in iron status biomarkers (serum ferritin, transferrin saturation, soluble transferrin receptor, serum hepcidin)Timepoint: Baseline, 90 days, and 365 days;Proportion of participants achieving hemoglobin greater than 12.0 g per dLTimepoint: 90 days and 365 days;Frequency and severity of gastrointestinal adverse effects (nausea, vomiting, constipation, diarrhea)Timepoint: During the 90-day intervention period;Association between menstrual blood loss (PBAC score) and hemoglobin responseTimepoint: Baseline and 90 days

—

Countries

India

Contacts

Public ContactDR C S SURYA GOUD

ICMR-National Institute Of Nutrition

suryagoud.cs@icmr.gov.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026