Iron absorption from salt double fortified with iodine in iron-deficient Indian women.

Not Applicable

• Registration Number: CTRI/2020/11/028936
• Lead Sponsor: Bill and Melinda Gates Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Written informed consent

Female, 18 to 40 years old

SF < 25 µg/L

Normal body Mass Index (18.5 â?? 25 kg/m2)

Bodyweight <= 65 kg

Exclusion Criteria

Pregnancy (assessed by self-declaration)

Lactating up to 6 weeks before study initiation

Anemia (Hb < 12.0 g/dL)

Elevated CRP ( >5.0 mg/L)

Consumption of mineral and vitamin supplements within 2 weeks before 1st meal administration

Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months

Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days

A participant who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)

Continuous/long-term use of medication during the whole study (except for contraceptives)

Any metabolic, gastrointestinal kidney or chronic diseases such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases

Smokers ( > 1 cigarette per week)

Difficulties with blood sampling

Male gender

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare encapsulated ferrous fumarate (FeFum) with co-encapsulated FePP and with solubilizing agents.Timepoint: 2:Baseline and Endline.

Secondary Outcome Measures

Name	Time	Method
To compare in iron-deficient Indian women (Serum Ferritin lesser than 25ug/L) fractional iron absorption (FIA) from double fortified with iodine and different iron compounds. <br/ ><br>To determine the iron status and inflammatory markers. <br/ ><br>To evaluate the sensory properties of the different double fortified salts in local foods using triangle and acceptability tests. <br/ ><br>To determine the stability of color and iodine concentration in double fortified salt during a 6-month storage trial. <br/ ><br>Timepoint: 2:Baseline and Endline.