Fermented Iron-rich Supplement in Reducing Anemia (FISRA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University of Ghana
Sponsor:
Information provided by (Responsible Party):
Richmond Aryeetey, PhD, MPH, University of Ghana
ClinicalTrials.gov Identifier:
NCT02037724
First received: January 14, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Iron Deficiency Anemia
Dietary Supplement: supplement containing 60 mg iron sulfate
Dietary Supplement: iron rich food supplement (60 mg iron)
Dietary Supplement: iron rich food supplement (10 mg iron)
Dietary Supplement: supplement containing 10 mg iron sulfate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Fermented Iron-rich Supplement in Reducing Anemia

Resource links provided by NLM:


Further study details as provided by University of Ghana:

Primary Outcome Measures:
  • iron deficiency anemia [ Time Frame: two and three months ] [ Designated as safety issue: No ]
    Improvement of iron status with 60 mg (after two months) and 10 mg iron (after 3 months) will be assessed. The iron status measurements include, hemoglobin, ferritin, transferrin receptor and whole blood count


Secondary Outcome Measures:
  • comparison of side effects of iron supplement [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    We expect to have less side effects with IRS compared with ferrous sulfate (as observed in previous studies) that include: constipation, diarrhea, vomiting, gastrointestinal distress, change in stool color and others. We will assess these with a questionnaire.


Other Outcome Measures:
  • minimum level of supplement intake needed to improve iron status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The effectiveness of low dose (10 mg daily iron) compared to higher dose (60mg daily iron) from the fermented organic food supplement product. These results will be helpful for using IRS as a food supplement.


Estimated Enrollment: 120
Study Start Date: March 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
supplement containing 60 mg iron sulfate
nutrient supplement containing 60 mg of iron as ferous sulfate
Dietary Supplement: iron rich food supplement (60 mg iron)
contains 60 mg of iron
Dietary Supplement: iron rich food supplement (10 mg iron)
contains 10 mg iron
Dietary Supplement: supplement containing 10 mg iron sulfate
control agent
Experimental: iron rich food supplement (60 mg iron)
contains 60 mg Iron
Dietary Supplement: supplement containing 60 mg iron sulfate
control agent
Dietary Supplement: iron rich food supplement (10 mg iron)
contains 10 mg iron
Dietary Supplement: supplement containing 10 mg iron sulfate
control agent
Experimental: iron rich food supplement (10 mg iron)
contains 10 mg of iron
Dietary Supplement: supplement containing 60 mg iron sulfate
control agent
Dietary Supplement: iron rich food supplement (60 mg iron)
contains 60 mg of iron
Dietary Supplement: supplement containing 10 mg iron sulfate
control agent
supplement containing 10 mg iron sulfate
nutrient supplement containing 10 mg of iron as ferous sulfate
Dietary Supplement: supplement containing 60 mg iron sulfate
control agent
Dietary Supplement: iron rich food supplement (60 mg iron)
contains 60 mg of iron
Dietary Supplement: iron rich food supplement (10 mg iron)
contains 10 mg iron

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037724

Contacts
Contact: Richmond Aryeetey, PhD 233244129669 raryeetey@ug.edu.gh

Sponsors and Collaborators
University of Ghana
Investigators
Principal Investigator: Richmond Aryeetey, PhD University of Ghana School of Public Health
Principal Investigator: Manju Reddy, PhD Iowa State University
  More Information

No publications provided

Responsible Party: Richmond Aryeetey, PhD, MPH, Senior Lecturer, University of Ghana
ClinicalTrials.gov Identifier: NCT02037724     History of Changes
Other Study ID Numbers: UG-0001-IDA
Study First Received: January 14, 2014
Last Updated: January 14, 2014
Health Authority: Ghana : Food and Drugs Board

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014