Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622551
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Different Efficacy of IFA Supplementation Among Obese and Non-obese Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Study of Association Between Obesity and Iron Deficiency Anaemia in Nonpregnant Indonesian Women
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to learn if there is a relationship between OWTOB 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 overweightobesity and iron deficiency anemia in nonpregnant women after controlling for potential confounding factors
Does the effect of iron supplementation on iron status vary between overweightobese 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 supplements intake
Is there any independent association between overweightobesity and iron deficiency anemia in nonpregnant women after controlling for potential confounding factors
Does the effect of iron supplementation on iron status vary between overweightobese 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 supplements intake
Detailed Description:
Anaemia is one of the major nutritional problems that brings many negative health consequences to womens health especially during pregnancy There was growing evidence that overweightobesity can lead to anaemia However the association between anaemia and overweightobesity has not been fully established especially in developing countries including Indonesia The prevalence of overweightobesity has sharply increased in Indonesia for the past decades while anaemia prevalence did not show a significant decrease The prevalence of anaemia in Indonesia was still alarming with 272 in nonpregnant women and 489 in pregnant women Indonesia MoH 2019a Therefore the study of the association between overweightobesity and anaemia among women of reproductive age in Indonesia needs to be conducted using appropriate measurements Furthermore previously available studies highly ignored the role of dietary intake in the association between overweightobesity and anaemia despite its importance This study will also measure dietary intake among women
Once participants agree to participate in this study the investigators will ask questions about themselves latest education history employment general health menstrual history smoking history and physical activity level The investigators will then ask the participants to write the food and beverages consumed in the dietary record form for 3-non consecutive days Then the investigators will ask about their dietary intake in the last 24 hours1 day foods the participants have taken and their approximate amount After that the investigators will take anthropometric measurements height weight and waist circumference to define nutritional status The investigators will also collect a small amount 3mL of blood samples from the participants two times before and after intervention Blood collection will be performed by trained nursesmedical analysts under a medical doctoramp39s supervision and collected at the university clinic The investigators will measure several parameters from that blood sample such as iron status parameters including hemoglobin serum ferritin and hepcidin and other chemicals in the blood that indicate inflammation AGP and CRP The results of these tests will be provided to all participants
After collecting these data participants will be assigned to one of the two study groups using matching criteria age education level and occupation Participants in all groups will receive iron supplements The participants will not be made aware of which arm they have been assigned to For the following three months the participants will receive approximately 90 iron supplements to be consumed every day The study staff will contact the participants through short messages and monthly visitation to ensure adherence to iron supplement consumption After three months the investigators will stop providing iron supplements The investigators will collect information about their dietary intake over the last day and retake their anthropometry measurements The investigators will also collect blood samples from participants and perform the same test as the previous one
The investigators have asked the subjects to participate in this study because the participants are women aged between 20 and 29 years neither pregnant nor lactating living in this area are healthy have not received any micronutrient supplementation in the last three months and have not undergoing body mass reduction or on any particular weight loss diet After anthropometric screening each participant will be assigned to a case or control group based on the Body Mass Index BMI results
Once participants agree to participate in this study the investigators will ask questions about themselves latest education history employment general health menstrual history smoking history and physical activity level The investigators will then ask the participants to write the food and beverages consumed in the dietary record form for 3-non consecutive days Then the investigators will ask about their dietary intake in the last 24 hours1 day foods the participants have taken and their approximate amount After that the investigators will take anthropometric measurements height weight and waist circumference to define nutritional status The investigators will also collect a small amount 3mL of blood samples from the participants two times before and after intervention Blood collection will be performed by trained nursesmedical analysts under a medical doctoramp39s supervision and collected at the university clinic The investigators will measure several parameters from that blood sample such as iron status parameters including hemoglobin serum ferritin and hepcidin and other chemicals in the blood that indicate inflammation AGP and CRP The results of these tests will be provided to all participants
After collecting these data participants will be assigned to one of the two study groups using matching criteria age education level and occupation Participants in all groups will receive iron supplements The participants will not be made aware of which arm they have been assigned to For the following three months the participants will receive approximately 90 iron supplements to be consumed every day The study staff will contact the participants through short messages and monthly visitation to ensure adherence to iron supplement consumption After three months the investigators will stop providing iron supplements The investigators will collect information about their dietary intake over the last day and retake their anthropometry measurements The investigators will also collect blood samples from participants and perform the same test as the previous one
The investigators have asked the subjects to participate in this study because the participants are women aged between 20 and 29 years neither pregnant nor lactating living in this area are healthy have not received any micronutrient supplementation in the last three months and have not undergoing body mass reduction or on any particular weight loss diet After anthropometric screening each participant will be assigned to a case or control group based on the Body Mass Index BMI results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None