Fermented Iron-rich Supplement in Reducing Anemia

NCT ID: NCT02037724

Last Updated: 2014-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-10-31

Brief Summary

The consequences of iron deficiency anemia in women are enormous, and especially in developing countries, as the condition adversely affects both their productive and reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators among women receiving an iron-rich organic food supplement versus ferrous sulfate supplement, and 2) determine the suitable level of food supplement needed to prevent/reduce iron deficiency anemia among women in developing country settings.

A double-blind, randomized, controlled, intervention trial will be implemented in women of childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency. After screening potential subjects (up to 500 expected), approximately 30 will be recruited into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in ferritin as significant between the two time points at 80% power and alpha value of 0.05. Subjects who meet the inclusion criteria will be randomized into the four groups consisting of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8 weeks while subjects taking FS-10 and IRS-10 will take the supplement under supervision for 12 consecutive weeks.

Detailed Description

The design will involve screening of about 500 female adult students and staff of the University of Ghana who meet initial the inclusion criteria. Screening will involve pregnancy testing, assessment of hemoglobin, and ferritin and also administration of a health history questionnaire.

Thereafter, 120 eligible subjects will enrolled and randomized to recieve the treatment. All subjects will complete 3-day dietary record (including 2 weekdays and 1 weekend) at baseline and at endline (i.e. one week prior to treatment completion). The dietary data will be analyzed using nationally-generated food composition tables together with the ESHA food processor software. In addition, body weight and height will be measured using standard methods at baseline and end of the study. Weekly monitoring of side effects will be recorded. Fasting blood samples will be collected at baseline and endline to enable determination of anemia status and other indicators including serum ferritin, transferrin receptor and full blood count, together with C-reactive protein.

Conditions

Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

supplement containing 60 mg iron sulfate

nutrient supplement containing 60 mg of iron as ferous sulfate

Group Type: OTHER

iron rich food supplement (60 mg iron)

Intervention Type: DIETARY_SUPPLEMENT

contains 60 mg of iron

iron rich food supplement (10 mg iron)

Intervention Type: DIETARY_SUPPLEMENT

contains 10 mg iron

supplement containing 10 mg iron sulfate

Intervention Type: DIETARY_SUPPLEMENT

control agent

iron rich food supplement (60 mg iron)

contains 60 mg Iron

Group Type: EXPERIMENTAL

supplement containing 60 mg iron sulfate

Intervention Type: DIETARY_SUPPLEMENT

control agent

iron rich food supplement (10 mg iron)

Intervention Type: DIETARY_SUPPLEMENT

contains 10 mg iron

supplement containing 10 mg iron sulfate

Intervention Type: DIETARY_SUPPLEMENT

control agent

iron rich food supplement (10 mg iron)

contains 10 mg of iron

Group Type: EXPERIMENTAL

supplement containing 60 mg iron sulfate

Intervention Type: DIETARY_SUPPLEMENT

control agent

iron rich food supplement (60 mg iron)

Intervention Type: DIETARY_SUPPLEMENT

contains 60 mg of iron

supplement containing 10 mg iron sulfate

Intervention Type: DIETARY_SUPPLEMENT

control agent

supplement containing 10 mg iron sulfate

nutrient supplement containing 10 mg of iron as ferous sulfate

Group Type: OTHER

supplement containing 60 mg iron sulfate

Intervention Type: DIETARY_SUPPLEMENT

control agent

iron rich food supplement (60 mg iron)

Intervention Type: DIETARY_SUPPLEMENT

contains 60 mg of iron

iron rich food supplement (10 mg iron)

Intervention Type: DIETARY_SUPPLEMENT

contains 10 mg iron

Interventions

supplement containing 60 mg iron sulfate

control agent

Intervention Type: DIETARY_SUPPLEMENT

iron rich food supplement (60 mg iron)

contains 60 mg of iron

Intervention Type: DIETARY_SUPPLEMENT

iron rich food supplement (10 mg iron)

contains 10 mg iron

Intervention Type: DIETARY_SUPPLEMENT

supplement containing 10 mg iron sulfate

control agent

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 18-49 years
• Regular menstruation in the last three months
• Hemoglobin <12 mg/dl;
• Serum Ferittin<20mcg/L
• BMI 18.5Kg/m^2 to 29.9 kg/m^2

Exclusion Criteria

• history of gastrointestinal or hematological disorders,
• taking medications that could interfere with hematopoiesis or dietary iron absorption
• pregnant (based on pregnancy test).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ghana

OTHER

Sponsor Role: lead

Responsible Party

Richmond Aryeetey, PhD, MPH

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richmond Aryeetey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ghana

Manju Reddy, PhD

Role: PRINCIPAL_INVESTIGATOR

Iowa State University

Central Contacts

Richmond Aryeetey, PhD

Role: CONTACT

raryeetey@ug.edu.gh

233244129669

Other Identifiers

UG-0001-IDA

Identifier Type: -

Identifier Source: org_study_id