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Effect of a New Chewable Iron-Based Nutritional Supplement on Improving Hemoglobin Levels in Mildly Anaemic Women of Reproductive Age in Tamil Nadu

Translational Evaluation of a Novel Chewable Iron Folic Acid Vitamin C Probiotic Nutritional Supplement for Hemoglobin Enhancement: From Cell Line Efficacy and Animal Safety to Phase II Clinical Evaluation in Mildly Anaemic Reproductive-Age Women of Tamil Nadu - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103362
Enrollment
220
Registered
2026-02-09
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: HAEMO-BITE PRO: Participants will receive a chewable nutritional supplement containing iron folic acid vitamin C and probiotic Lactobacillus rhamnosus GG for two months. The supplement

Sponsors

Srinivasan S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Female participants aged 18 45 years with mild anaemia, defined as hemoglobin levels between 10.0 and 11.9 g/dL, who are willing to provide written informed consent will be included in the study. Participants must be residents of the study area and available for the entire study duration, including scheduled follow-up visits.

Exclusion criteria

Exclusion criteria: Participants will be excluded if they are male individuals outside the age range of 18 45 years, have moderate or severe anaemia hemoglobin less than 10 g/dL, are pregnant or lactating, have known hemoglobinopathies or any chronic medical illness, are currently receiving iron therapy or probiotic supplementation, or have a history of hypersensitivity or allergy to any of the study ingredients.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the change in hemoglobin concentration g/dL from baseline to the end of the intervention period at 2 months 8 weeks. Hemoglobin levels will be assessed at baseline Day 0 and at the completion of 2 months.Timepoint: Outcome will be estimated at baseline, 4 weeks and 8 weeks

Secondary

MeasureTime frame
The secondary outcomes include gastrointestinal tolerability assessed by the occurrence of symptoms such as nausea, constipation, abdominal discomfort, or diarrhea, participant compliance assessed by tablet count & self report, & the incidence of adverse events recorded during the 2 month intervention periodTimepoint: Outcome will be estimated at baseline, 4 weeks & 8 weeks

Countries

India

Contacts

Public ContactSrinivasan S

SAVEETHA MEDICAL COLLEGE AND HOSPITAL

SRINIVASANS8265@GMAIL.COM08667249231

Outcome results

None listed

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