Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437080
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-21
Brief Title:
Hypoferritinemia Without Anemia Among Reproductive Age Females
Sponsor:
Akram Medical Complex
Organization:
Akram Medical Complex
Study Overview
Official Title:
Hypoferritinemia Without Anemia Among Reproductive Age Females Frequency Determinants and Treatment Outcomes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized controlled trial is to compare the treatment outcomes of oral iron supplementation Group A versus Intravenous IV iron supplementation Group B versus normal diet no treatment Group C on the serum ferritin level and to determine the outcomes in the severity of symptoms of HWA among reproductive age females age 18-45 with hypoferritinemia without Anemia HWA after four months of the start of the intervention
The main questions it aims to answer are
1 What are the main determinants of HWA
2 There is no difference difference in the treatment outcomes after intervention
3 There is no difference difference in the severity of symptoms of HWA after intervention
Participants will
Randomly divided into 3 groups A B and C to receive treatment
100 patients will be allocated to each of the three study groups ie group A B and C The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq to Elemental Iron 100 mg Fersip daily for three months participants of group B will get IV Ferric Carboxymaltose Ferinject for 03 months 3 doses and Group C will remain on their normal diet
Visit the clinic once every 1 month for 03 months for doses and assessment of symptoms and adverse events will be done
All 03 groups will be called after one month of the last dose and the blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and the severity of symptoms to assess the effectiveness of the intervention
The main questions it aims to answer are
1 What are the main determinants of HWA
2 There is no difference difference in the treatment outcomes after intervention
3 There is no difference difference in the severity of symptoms of HWA after intervention
Participants will
Randomly divided into 3 groups A B and C to receive treatment
100 patients will be allocated to each of the three study groups ie group A B and C The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq to Elemental Iron 100 mg Fersip daily for three months participants of group B will get IV Ferric Carboxymaltose Ferinject for 03 months 3 doses and Group C will remain on their normal diet
Visit the clinic once every 1 month for 03 months for doses and assessment of symptoms and adverse events will be done
All 03 groups will be called after one month of the last dose and the blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and the severity of symptoms to assess the effectiveness of the intervention
Detailed Description:
At present the commonly identified presentation is Iron Deficiency Anemia which currently affects more than 1 billion people while Hypoferritenemia without Anemia HWA is at least twice as common HWA is poorly recognized by clinicians despite its high prevalence probably because of suboptimal screening recommendations
HWA Patients having normal Hemoglobin of 12 gdl and having below normal range ferritin level 30ngml and patients suffering from any of the following symptoms of
Fatigue tiredness
Poor work productivity
Poor attention
Poor memory
Sore tongue
Poor condition of skin nails or hair including hair loss
Delayed skin wound healing
Palpitation
Restless Leg Syndrome
As the symptoms and signs of the HWA are nonspecific which may happen in other systemic diseases or psychiatric disorders so patients with HWA are either recommended no tests or later on end up with expensive tests for heart failure and renal failure on the other end which can be the result of chronic iron deficiency Clinicians usually advise iron studies when there is documented anemia which results in underdiagnoses of HWA
In United Kingdom National Diet and Nutrition Survey 20082009-20112012 were conducted The study found that around 155 of women of 19 to 64 years of age had serum ferritin levels 15ng ml Adams White 2015 Another National survey conducted in US found that around 11 of the women belonging to 18 to 49 years of age had plasma ferritin levels 12ng ml
In another study conducted in Iran 2020 serum ferritin levels were observed among 120 females The sample was selected from the outpatient department of a medicine clinic The blood samples of the participants were obtained to have a complete account of their CBC and serum ferritin levels Results revealed that 417 of the patients had severe iron deficiency with low level of serum ferritin values value 10ngml Among symptoms of iron deficiency the most common symptom reported among 792 patients was fatigue Other symptoms include hair loss reported by 733 dizziness reported by 700 headache reported by 658 poor concentration reported by 617 palpitation by 600 chest pain by 558 and legs pain by 475 of the participants Among females of younger age group less than 25 years lower levels of serum ferritin were associated with heavy menstrual bleeding Whereas among females of older age group above 25 years of age poor nutrition reported to be a significant risk factor of low serum ferritin values In conclusion the study addressed low serum ferritin without anemia as a concealed disease that should be addressed by considering its treatment and diagnosis because patients with normal hemoglobin levels can develop iron deficiency anemia within days after diagnosis
To the best of researchers knowledge no study related to HWA has been conducted in Pakistan therefore the prevalence of Iron Deficiency Anemia IDA in Pakistan has been added in the present literature review Results show that a total of 45 of population is suffering from IDA in Pakistan
The rationale of this study is to highlight the struggling issue of HWA which is battling to be recognized as one of the factors contributing to the symptoms indicated above as was previously stated This study is important to be conducted as it will not only pave ways to recognize the category of HWA but will also help patients to receive targeted treatment and saving them from the risk of drug abuse and over-medication As per the researchers knowledge there is a scarcity of data on Pakistans population as no study exists on HWA in Pakistan
Above literature review clearly reflects that there is a wide gap regarding some aspects of HWA First it is an underdiagnosed entity as it has nonspecific symptoms which can be found in other diseases Although there are estimates of disease burden but exact value is not known especially in developing countries Secondly there is a lot of data regarding causes of iron deficiency but paucity exists regarding determinantscauses of HWA Thirdly there is contrary data regarding management few investigators believe that oral iron therapy shall be the first line therapy while other believes that intravenous IV therapy shall be given first to reduce symptoms
OBJECTIVES
1 To determine the frequency and Determinants of HWA among women of reproductive age
2 To compare the treatment outcomes of oral iron supplementation Group 1 versus Intravenous IV iron supplementation Group 2 versus normal diet Group 3 on the serum ferritin level after four months of start of intervention
3 To determine the outcomes in the severity of symptoms of HWA after four months of start of intervention
DETERMINANTS OF HWA
Heavy menstrual bleeding
Blood donation history
Blood transfusion history
Dietary intake
Number of pregnancies
Current status of lactation
Family history of Anemia
History of blood diseases
Medication history of vitamins minerals or any other supplementation
History of Drugs intake
Disturbed Thyroid level and Blood Sugar levels
Various co-morbidities or clinical conditions including celiac disease hemorrhoids malignancies hematuria heart disease renal failure chronic gastric symptoms gastric ulcers delayed wound healing and chronic liver disease
The Symptom Severity Scale is a self-administered questionnaire that has been adapted from Spies-Derglo et al to assess the severity of symptoms in patients
DATA COLLECTION TOOL
For data collection a structured close-ended questionnaire will be used The developed questionnaire has six sections
1 The first section consists of 5 qualifying question asking about age premature menopause blood transfusion history supplementation history and history of any symptom of HWA Defined above
2 The second section will record the socio-demographic characteristics of the participants including education monthly family income region of residence religion working status marital status and the number of children and the utilization of antenatal care if ever pregnant
3 The third section will be used to record the determinants leading to low serum ferritin levels including blood donation history current lactation and pregnancy status number of pregnancies family history of Anemia Menorrhagia heavy menstrual bleeding blood diseases history of intake of medication other than supplements and vitamins history of co-morbidities and frequency of meals per day The dietary score will also be measured using an individual DDS questionnaire The score of DDS will be then recoded into different categories 3 as low 4-5 as moderate and 6 as high dietary diversity according to the Guidelines for measuring household and Individual Dietary Diversity
4 The fourth section will record the serum ferritin CBC thyroid and blood sugar levels of the participants determined through lab tests Participants having Vitamin B12 deficiency Folic Acid deficiency serum ferritin values 10ngmL disturbed thyroid and blood sugar levels any chronic conditions will not be included in RCT
5 Fifth section will inquire about the severity of clinical symptoms of participants at Visit 1 using a symptom severity scale to record baseline data
6 The last section will be used to record the occurrence of adverse events followed by the administration of supplementation dosage to the participants of group A and B at visits 2 3 4 and 5 Serum ferritin value at visit 5 and the incidence and severity of clinical symptoms of HWA among patients at visit 5 Last question in section six will enquire about the subjective knowledge of participants regarding improvement in their symptoms before and after the intervention
DATA COLLECTION PROCESS Cross-Sectional Study Study participants will be selected from four hospitals of Lahore through simple random sampling technique Patients will be enrolled after meeting inclusion and exclusion criteria and filling of questionnaire during face to face interviews At the end of each interview the blood sample will be taken Their blood will be tested for CBC and serum ferritin values at the end of the face to face interview Informed written consent will be taken from each respondent before the start of the interview
Randomized Control Trial RCT
Females having normal CBC hemoglobin level above 12mgdl and serum ferritin level below 30 ngml and normal thyroid and blood sugar levels will be selected for the intervention
Females will be randomly assigned to three study groups
After randomization 100 patients will be allocated to each of the three study groups ie group A B and C The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq to Elemental Iron 100 mg Fersip daily for three months participants of group B will get IV Ferric Carboxymaltose Ferinject for 03 months 3 doses and Group C will remain on their normal diet
Assessment of symptoms and adverse event will be done
All 03 groups will be called and their blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention
HWA Patients having normal Hemoglobin of 12 gdl and having below normal range ferritin level 30ngml and patients suffering from any of the following symptoms of
Fatigue tiredness
Poor work productivity
Poor attention
Poor memory
Sore tongue
Poor condition of skin nails or hair including hair loss
Delayed skin wound healing
Palpitation
Restless Leg Syndrome
As the symptoms and signs of the HWA are nonspecific which may happen in other systemic diseases or psychiatric disorders so patients with HWA are either recommended no tests or later on end up with expensive tests for heart failure and renal failure on the other end which can be the result of chronic iron deficiency Clinicians usually advise iron studies when there is documented anemia which results in underdiagnoses of HWA
In United Kingdom National Diet and Nutrition Survey 20082009-20112012 were conducted The study found that around 155 of women of 19 to 64 years of age had serum ferritin levels 15ng ml Adams White 2015 Another National survey conducted in US found that around 11 of the women belonging to 18 to 49 years of age had plasma ferritin levels 12ng ml
In another study conducted in Iran 2020 serum ferritin levels were observed among 120 females The sample was selected from the outpatient department of a medicine clinic The blood samples of the participants were obtained to have a complete account of their CBC and serum ferritin levels Results revealed that 417 of the patients had severe iron deficiency with low level of serum ferritin values value 10ngml Among symptoms of iron deficiency the most common symptom reported among 792 patients was fatigue Other symptoms include hair loss reported by 733 dizziness reported by 700 headache reported by 658 poor concentration reported by 617 palpitation by 600 chest pain by 558 and legs pain by 475 of the participants Among females of younger age group less than 25 years lower levels of serum ferritin were associated with heavy menstrual bleeding Whereas among females of older age group above 25 years of age poor nutrition reported to be a significant risk factor of low serum ferritin values In conclusion the study addressed low serum ferritin without anemia as a concealed disease that should be addressed by considering its treatment and diagnosis because patients with normal hemoglobin levels can develop iron deficiency anemia within days after diagnosis
To the best of researchers knowledge no study related to HWA has been conducted in Pakistan therefore the prevalence of Iron Deficiency Anemia IDA in Pakistan has been added in the present literature review Results show that a total of 45 of population is suffering from IDA in Pakistan
The rationale of this study is to highlight the struggling issue of HWA which is battling to be recognized as one of the factors contributing to the symptoms indicated above as was previously stated This study is important to be conducted as it will not only pave ways to recognize the category of HWA but will also help patients to receive targeted treatment and saving them from the risk of drug abuse and over-medication As per the researchers knowledge there is a scarcity of data on Pakistans population as no study exists on HWA in Pakistan
Above literature review clearly reflects that there is a wide gap regarding some aspects of HWA First it is an underdiagnosed entity as it has nonspecific symptoms which can be found in other diseases Although there are estimates of disease burden but exact value is not known especially in developing countries Secondly there is a lot of data regarding causes of iron deficiency but paucity exists regarding determinantscauses of HWA Thirdly there is contrary data regarding management few investigators believe that oral iron therapy shall be the first line therapy while other believes that intravenous IV therapy shall be given first to reduce symptoms
OBJECTIVES
1 To determine the frequency and Determinants of HWA among women of reproductive age
2 To compare the treatment outcomes of oral iron supplementation Group 1 versus Intravenous IV iron supplementation Group 2 versus normal diet Group 3 on the serum ferritin level after four months of start of intervention
3 To determine the outcomes in the severity of symptoms of HWA after four months of start of intervention
DETERMINANTS OF HWA
Heavy menstrual bleeding
Blood donation history
Blood transfusion history
Dietary intake
Number of pregnancies
Current status of lactation
Family history of Anemia
History of blood diseases
Medication history of vitamins minerals or any other supplementation
History of Drugs intake
Disturbed Thyroid level and Blood Sugar levels
Various co-morbidities or clinical conditions including celiac disease hemorrhoids malignancies hematuria heart disease renal failure chronic gastric symptoms gastric ulcers delayed wound healing and chronic liver disease
The Symptom Severity Scale is a self-administered questionnaire that has been adapted from Spies-Derglo et al to assess the severity of symptoms in patients
DATA COLLECTION TOOL
For data collection a structured close-ended questionnaire will be used The developed questionnaire has six sections
1 The first section consists of 5 qualifying question asking about age premature menopause blood transfusion history supplementation history and history of any symptom of HWA Defined above
2 The second section will record the socio-demographic characteristics of the participants including education monthly family income region of residence religion working status marital status and the number of children and the utilization of antenatal care if ever pregnant
3 The third section will be used to record the determinants leading to low serum ferritin levels including blood donation history current lactation and pregnancy status number of pregnancies family history of Anemia Menorrhagia heavy menstrual bleeding blood diseases history of intake of medication other than supplements and vitamins history of co-morbidities and frequency of meals per day The dietary score will also be measured using an individual DDS questionnaire The score of DDS will be then recoded into different categories 3 as low 4-5 as moderate and 6 as high dietary diversity according to the Guidelines for measuring household and Individual Dietary Diversity
4 The fourth section will record the serum ferritin CBC thyroid and blood sugar levels of the participants determined through lab tests Participants having Vitamin B12 deficiency Folic Acid deficiency serum ferritin values 10ngmL disturbed thyroid and blood sugar levels any chronic conditions will not be included in RCT
5 Fifth section will inquire about the severity of clinical symptoms of participants at Visit 1 using a symptom severity scale to record baseline data
6 The last section will be used to record the occurrence of adverse events followed by the administration of supplementation dosage to the participants of group A and B at visits 2 3 4 and 5 Serum ferritin value at visit 5 and the incidence and severity of clinical symptoms of HWA among patients at visit 5 Last question in section six will enquire about the subjective knowledge of participants regarding improvement in their symptoms before and after the intervention
DATA COLLECTION PROCESS Cross-Sectional Study Study participants will be selected from four hospitals of Lahore through simple random sampling technique Patients will be enrolled after meeting inclusion and exclusion criteria and filling of questionnaire during face to face interviews At the end of each interview the blood sample will be taken Their blood will be tested for CBC and serum ferritin values at the end of the face to face interview Informed written consent will be taken from each respondent before the start of the interview
Randomized Control Trial RCT
Females having normal CBC hemoglobin level above 12mgdl and serum ferritin level below 30 ngml and normal thyroid and blood sugar levels will be selected for the intervention
Females will be randomly assigned to three study groups
After randomization 100 patients will be allocated to each of the three study groups ie group A B and C The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq to Elemental Iron 100 mg Fersip daily for three months participants of group B will get IV Ferric Carboxymaltose Ferinject for 03 months 3 doses and Group C will remain on their normal diet
Assessment of symptoms and adverse event will be done
All 03 groups will be called and their blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None