Different Efficacy of IFA Supplementation Among Obese and Non-obese Women

NCT06622551 | Enrolling By Invitation DMC

• 4 other identifiers: GU Ref No: 2024/2283433/BPPT/BPI.LG/V/2024119/EA/KEPK/2024U1111-1313-7880
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to learn if there is a relationship between OWT/OB and IDA in nonpregnant women of reproductive age and its impact on iron supplementation. The main questions it aims to answer are:

• Is there any independent association between overweight/obesity and iron deficiency anemia in nonpregnant women after controlling for potential confounding factors?
• Does the effect of iron supplementation on iron status vary between overweight/obese and normal-weight nonpregnant women (as measured by multiple iron biomarkers)? Researchers will compare several biomarkers between the case and control groups after the intervention is given for 90 days. Participants will:
• Visit the research center before the intervention given and after 90 days
• Take daily iron-folic acid supplements for 90 days
• Keep a diary of their supplement's intake

Conditions

Obesity and Overweight; Anemia, Iron-Deficiency

Keywords

Obesity; Iron folic acid supplemet; Anemia; Women of reproductive age; Indonesia

Outcome Measures

Primary Outcomes (7)

• Number of participants with Iron Deficiency Anemia (IDA)

  From enrollment to the end of treatment at 90 days

• Concentration of Hemoglobin

  Concentration of Hb will be measured in g/dL

  Day 0 (Before intervention) and Day 90 (After intervention)

• Concentration of Ferritin

  Aims to assess iron deficiency among women; will be measured in ng/mL

  Day 0 (Before intervention) and Day 90 (After intervention)

• Concentration of Hepcidin

  Concentration of Hepcidin will be measured in ng/mL

  Day 0 (Before intervention) and Day 90 (After intervention)

• Overweight and obese prevalence

  To achieve this outcome, weight will be measured in Kilograms and height will be measured in centimeters. Weight and height will be combined to report BMI in kg/m\^2.

  Day 0 (Before intervention) and Day 90 (After intervention)

• Concentration of CRP

  The concentration of CRP will be measured in mg/L

  Day 0 (Before intervention) and Day 90 (After intervention)

• Concentration of AGP-1

  The concentration of AGP-1 will be measured in mg/dL

  Day 0 (Before intervention) and Day 90 (After intervention)

Study Arms (2)

Overweight/obese arm

EXPERIMENTAL

In this arm, those who are overweight and obese will be assigned. Each participant will be given 90 days of IFA supplement.

Dietary Supplement: Iron-folic acid supplement

Normal-weight arm

ACTIVE COMPARATOR

In this arm, those with normal-weight will be assigned. Each participant will be given 90 days of IFA supplement.

Dietary Supplement: Iron-folic acid supplement

Interventions

Iron-folic acid supplement DIETARY_SUPPLEMENT

The major thing distinguishing this clinical study from another clinical trial is that we differentiate intervention based on nutritional status as we want to observe whether different nutritional status, especially overweight/obese will diminish the effect of IFA supplementation.

Normal-weight arm; Overweight/obese arm

Eligibility Criteria

• Age: 20 Years - 29 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nonpregnant, nonlactating women aged 19 - 29 years
• Never been married and pregnant.
• Having no menstrual abnormality (amenorrhea, polymenorrhea, etc.)
• Able to read and write in Bahasa Indonesia
• Not undergoing body mass reduction or on any particular weight loss diet

You may not qualify if:

• BMI \<18.5 kg/m2
• Self-reported specific diseases that need diet modification (i.e., type 1 diabetes, kidney disease, autoimmune disease, etc.)
• Self-report of significant medical conditions (e.g., diabetes mellitus, disorders of the liver \[including hemochromatosis\] and kidney, autoimmune or metabolic diseases, and malignancy\] or use of medications that may influence weight, iron, or inflammatory status; pregnancy or lactation; vegetarianism; zinc supplementation; smoking habit.

Sponsors & Collaborators

• Griffith University: lead
• Universitas Airlangga: collaborator

Study Sites (1)

Nutrition Laboratory, Faculty of Public Health Universitas Airlangga

Surabaya, East Java, 60115, Indonesia

Location

MeSH Terms

Conditions

Obesity; Overweight; Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases

Study Officials

• Faruk Ahmed, Convenor

  Griffith University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 2, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 30, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available from January 2025 until the next 5 years.
• Access Criteria: Only the study investigators from Griffith University (QLD, Australia) will have access to your personal information.

Locations

ID (1)