PRobiotics in Anemia Trial for Healthy Aging Management

Impact of supplementation of a package of iron folic acid (IFA) with probiotics on hemoglobin levels in elderly with mild to moderate anemia: A double blind randomized controlled trial - PRATHAM

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057830

Enrollment

200

Registered

2023-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Health Condition 1: E611- Iron deficiency

Interventions

Intervention1: Tablet Iron Folic Acid Capsule containing Probiotics: Daily once supplementation of iron folic acid tablet (containing 60 mg of elemental iron and 500mcg of folic acid) for 12 weeks and

Eligibility

Inclusion criteria

Inclusion criteria: Individuals aged 60 years and above, a permanent resident of the area, are expected to stay in the area for 6 months following enrolment, gives consent to participate in the study, screened to have mild to moderate anemia and have not taken any probiotic or antibiotics in the past 30 days prior to enrolment will be included in the present study

Exclusion criteria

Exclusion criteria: Individuals with no anemia (Male: Hemoglobin >13gm/dl and Female: Hemoglobin >12gm/dl), with severe anemia (Hemoglobin <8gm/dl), known history of gastrointestinal & metabolic disorders, chronic renal failure, received blood donations in last 6 months and regularly consuming nutritional supplements (Iron, folic acid, Vitamin B12, Vitamin D and other multivitamins and minerals), diagnosed cases of pancreatitis, hypersensitivity to any ingredient in the supplement and those who participated in any other clinical trial in the preceding 30 days will be excluded from the study

Design outcomes

Primary

Measure	Time frame
To determine the impact of supplementation of a therapeutic package of Iron & Folic Acid & probiotics on hemoglobin level in elderly with mild to moderate anemia in comparison to IFA onlyTimepoint: From baseline to 12 weeks of intervention	—

Secondary

Measure	Time frame
To compare the change in composition & diversity of the gut microbiome between two groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on CRP level in both the groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on ferritin concentration in both the groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on hepcidin level in both the groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on incidence of acute infections in both the groupsTimepoint: From baseline to 12 weeks of intervention	—

Measure

Time frame

To compare the change in composition & diversity of the gut microbiome between two groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on CRP level in both the groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on ferritin concentration in both the groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on hepcidin level in both the groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on incidence of acute infections in both the groupsTimepoint: From baseline to 12 weeks of intervention

—

Countries

India

Contacts

Public ContactDr Farhad Ahamed

All India Institute of Medical Sciences Kalyani

farhad.cmfm@aiimskalyani.edu.in9711813486

Outcome results

None listed

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