Hypoferritinemia Without Anemia Among Reproductive Age Females: Frequency, Determinants and Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Symptom severity scale
研究概览
简要总结
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 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.
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 i.e., 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 get no treatment.
详细描述
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 g/dl and having below normal range ferritin level < 30ng/ml 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.
To the best of researcher's 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Reproductive age females: 18 to 45 years
- •Clinical symptoms of iron deficiency which are fatigue/ tiredness, poor work productivity, poor attention and memory loss, sore tongue, poor condition of skin, nails or hair, including hair loss, delayed skin wound healing, palpitation and restless leg syndrome
- •Normal CBC: hemoglobin level12mg/dl and above
- •Serum ferritin levels: below 30 ng/ml
- •Normal thyroid levels
- •Normal blood sugar levels
- •Willing and able to sign informed consent
排除标准
- •Post-menopausal
- •Premature menopause
- •Anemic Females: hemoglobin levels i.e. less than 12 g/dl
- •Serum ferritin level above 30 ng/ml.
- •Disturbed thyroid levels
- •Disturbed blood sugar levels
- •Lactating
- •Blood donors
- •Co-morbidities i.e., celiac disease, hemorrhoids, malignancies, hematuria, ulcers, heart failure, renal failure, chronic gastric symptoms/ gastric ulcers, chronic liver disease, disturbed thyroid levels and diabetes
- •Any medication or supplement which may impact iron metabolism.
- •History of iron or multivitamins supplementation in the last 3 months
研究组 & 干预措施
Oral iron supplement
100 participants of Group A will get oral iron supplementation (Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron), 100 mg for 03 months. Participants will consume 01 tablet per day for 03 months.
After completion of the treatment period 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.
干预措施: Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg (Drug)
Normal diet
100 participants will remain on their normal diet for 03 months. After 03 months 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.
Intravenous (IV) iron supplementation
100 participants of Group B will get IV iron supplementation (Ferric Carboxymaltose) for 03 months (01 dose per month for 03 months).
After completion of the treatment period 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.
干预措施: Ferric Carboxymaltose (Drug)
结局指标
主要结局
Symptom severity scale
时间窗: Week 1 (Baseline)
Symptom severity score before intervention: This questionnaire contains eight questions with multiple-choice responses, with a score ranging from 0 point (not at all), 1 point (mild symptoms/ rarely), 2 points (moderate/ sometimes) and 3 points (severe/ frequently). The total symptom severity score will be calculated as the mean of the scores for the eight individual items and will be recorded at week 1
Determinants of Serum Ferritin value
时间窗: Week 1 (Baseline)
A questionnaire will be use to access the determinants. The questions included are blood donation history, vitamin supplementation drug, medication history, total preganacies, currently pregnant or lactating, heavy menstural bleeding, number of days of menstural bleeding and pads changed, frequency of stools per day, family history of anemia, frequency of meals per day and meal skipping
Socio demographic characteristics of participants
时间窗: Week 1 (Baseline)
The characteristics that will be surveyed at level of education, region, religion, income, marital status, number of children, antenatal care and working status
Dietary Diversity questionnaire
时间窗: Week 1 (Baseline)
For pattern of diet intake: History regarding daily meal frequency and skipping meals and 24 hour recall dietary of an individual will be surveyed: The score of all food groups will then be computed to get the final DDS. DDS of ≤3 will be considered low, 4-5 will be considered as moderate and ≥6 will be considered as a high DDS.
Hemoglobin levels
时间窗: week 1 (Baseline)
Complete blood count (CBC)
Thyroid-stimulating hormone (TSH)
时间窗: Week 2
Thyroid functions
Serum ferritin levels
时间窗: Week 1 (Baseline)
Serum ferritin levels before intervention
Random blood sugar
时间窗: Week 2
blood sugar levels
次要结局
- Adverse events(Week 6, 10, 16)
- Symptom severity scale(Week 6, 10, 16)
- Change in serum ferritin levels as result of oral intervention: Fersip(Week 16)
- Change in serum ferritin levels as result of intravenous (IV) iron intervention: Ferinject(Week 16)
- Comparison of treatment outcomes of groups (A, B and C)(Week 16)
研究者
Shehla Javed Akram
Student
University of Lahore