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Iron and vitamin D trial among elderly of India

Impact of supplementation of a package of iron folic acid (IFA) with vitamin D3 on hemoglobin levels in elderly with mild to moderate anemia: A double blind randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042775
Enrollment
300
Registered
2022-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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: IFA and Vitamin D3: Study participants in this group will receive daily 60 mg of elemental oral iron therapy as IFA tablets and 1500 IU of vitamin D3 as capsule for three months. The pa

Sponsors

Indian Council of Medical Research
Lead Sponsor

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 another six months, gives consent to participate in the study, screened to have mild to moderate anemia and absence of vitamin D deficiency will be eligible for the 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, known history of 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) will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Change in hemoglobin level in both the groupsTimepoint: From base line to 12 weeks

Secondary

MeasureTime frame
Change in CRP level in both the groupsTimepoint: From base line to 12 weeks;Change in hepcidin level in both the groupsTimepoint: From base line to 12 weeks;Change in Para Thyroid Hormone level in both the groups.Timepoint: From base line to 12 weeks;Change in serum ferritin level in both the groupsTimepoint: From base line to 12 weeks;Change in vitamin D level in both the groupsTimepoint: From base line to 12 weeks

Countries

India

Contacts

Public ContactFarhad Ahamed

AIIMS Kalyani

farhad.cmfm@aiimskalyani.edu.in9711813486

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026