Testing of availability of iron on absorption and compliance to biscuits fortified with iron fortified biscuits

Proof of Concept of a Culturally Appropriate Iron Fortified Biscuit to Reduce Maternal and Perinatal Anemia - POC IB

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/008009

Enrollment

118

Registered

2017-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: The intervention consists of iron fortified food prototype biscuits and a placebo tablet.: The manufacturer of iron fortified biscuits is approved by the FSSAI of India. The placebo ta

Eligibility

Inclusion criteria

Inclusion criteria: Urban pregnant women in the 2nd trimester of pregnancy and with a desire for an alternative to the iron pill will be included in the study.

Exclusion criteria

Exclusion criteria: 1) Evidence of disease of any organ systems or major health complication in the past 3 months, 2) evidence of any hormonal/metabolic disease such as diabetes mellitus or evidence of PIH, 3) evidence of chronic infections such as HIV, venereal disease, 4) severely anemic, 5) known or suspected allergies to supplement ingredients, and 6) those not regular to the OPD.

Design outcomes

Primary

Measure	Time frame
â?¢ To demonstrate hemoglobin (Hb) and serum iron levels with the iron fortified biscuit prototype similar to the iron pill after intervention with the formulated prototype in the form of biscuit, proving the efficacy of the biscuit during pregnancyTimepoint: 2nd trimester during pregnancy	—

Secondary

Measure	Time frame
To examine womenâ??s preferences during pregnancy for consuming their oral iron supplementation in the form of a food based biscuit or tablet.Timepoint: A subset of pregnant women to receive a 1-week supply of iron pills and 1-week supply of iron biscuits during 2nd trimester.;To measure the relative bioavailability of iron from our food-based prototype compared to the traditional iron pill.Timepoint: Baseline and endline assessment of serum bio-markers with a week apart	—

Measure

Time frame

To examine womenâ??s preferences during pregnancy for consuming their oral iron supplementation in the form of a food based biscuit or tablet.Timepoint: A subset of pregnant women to receive a 1-week supply of iron pills and 1-week supply of iron biscuits during 2nd trimester.;To measure the relative bioavailability of iron from our food-based prototype compared to the traditional iron pill.Timepoint: Baseline and endline assessment of serum bio-markers with a week apart

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Countries

India

Contacts

Public ContactDr Pratibha Dwarkanath

St. Johns Research Institute

pratibhadwarka@gmail.com918049466326

Outcome results