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the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients

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ClinicalTrials.gov Identifier: NCT02631668
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
xiao-qin wang, Huashan Hospital

Tracking Information
First Submitted Date  ICMJE December 14, 2015
First Posted Date  ICMJE December 16, 2015
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE January 1, 2016
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
Hemoglobin [ Time Frame: two weeks ]
The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the second week
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
  • Reticulocyte [ Time Frame: two weeks ]
    The increased levels of reticulocyte after receiving three different treatment regimens are evaluated in the second week
  • Hemoglobin [ Time Frame: four weeks ]
    The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the fourth week
  • Ferritin [ Time Frame: eight weeks ]
    The increased levels of ferritin after receiving three different treatment regimens are evaluated in the eighth week
  • adverse events [ Time Frame: every two weeks ]
    The incidence of adverse events every two weeks are assessed, the adverse events include bellyache, diarrhea, constipation, vomiting, nausea.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients
Official Title  ICMJE The Efficacy and Safety of Vitamin C for Iron Supplementation Therapy in Adult Patients With Iron Deficiency Anemia(IDA)
Brief Summary IDA patients ofen receive ferrous succinate treatment to speed up the recovery of anemia, the doctor will prescribe ferrous succinate with or without vitamin C according to their own preferences. In theory, only the divalent iron can be absorbed in duodenum and upper jejunum, vitamin C can oxidize ferric iron into divalent iron and maintains a certain degree of acidity in the intestine, and then promotes the absorption of iron. In current clinical practice, it's lack of randomized controlled trial(RCT) about the efficacy and safety of vitamin C for iron supplementation in patients with IDA. In this study, the efficacy and safety of vitamin C for iron supplementation in adult IDA patients are explored by RCT. The dosage regimens of ferrous succinate with or without vitamin C are randomly assigned to patients who meet the inclusion criteria, and these patients are followed up every two weeks. On the one hand, whether the addition of vitamin C can accelerate the recovery of anemia is evaluated, on the other hand, whether the addition of vitamin C can increase the incidence of gastrointestinal tract discomfort is aslo appraised , the discomfort include vomiting, nausea, abdominal pain, diarrhea and constipation. We hypothesis that vitamin C can increase the absorption of iron and accelerate the recovery of anemia, it also increases incidence of gastrointestinal adverse events because of increased iron absorption at the same time.
Detailed Description

BACKGROUND Iron deficiency(ID) causes approximately half of all anemia cases worldwide, a moderate degree of iron-deficiency anemia(IDA) affected approximately 610 million people worldwide or 8.8% of the population. It is slightly more common in female (9.9%) than males (7.8%). In 2013, anemia due to iron deficiency resulted in about 183,000 deaths. IDA is an urgent problem to be solved.

Iron deficiency anemia(IDA) is anemia due to not enough iron. Anemia is defined as a decrease in the amount of red blood cells (RBCs) or hemoglobin in the blood. It is caused by insufficient dietary intake and absorption of iron, or iron loss from bleeding. In babies and adolescents, rapid growth may outpace dietary intake of iron, and result in deficiency without disease or grossly abnormal diet. In women of childbearing age, heavy or long menstrual periods can also cause mild iron-deficiency anemia. Anemia is sometimes treatable, but certain types of anemia may be lifelong. If the cause is dietary iron deficiency, eating more iron-rich foods, such as beans, lentils or red meat, or taking iron supplements will usually correct the anemia.

In clinic, IDA clinically divided into three stages: ID, iron deficiency erythropoiesis (iron deficiency erythropoiesis, IDE) and IDA. The first stage is the reduction of iron storage, and there is a history of inadequate iron absorption; the second stage is the IDE, in addition to iron reduction or lack of external storage, transferrin is also reduced, the intake of iron in red blood cells is reduced compared to normal condition at this time; IDA is the last stage of iron deficiency. If the patients are diagnosed with ID and this condition can be corrected by diet therapy; if it reaches the IDA criteria, it's need to take iron orally and improve symptoms as soon as possible, but the most important is to find the cause of iron deficiency. Ferrous succinate is commonly used to treat IDA in clinic, mainly absorbed in the duodenum and proximal jejunum in the form of ferrous iron. In health people, 5% to 10% of the iron are absorbed after taken orally. the absorption proportion is increased to 20%~30% in IDA patients. After absorbed, ferrous iron can bind to transferrin and enter the blood circulation, and then involve in the production of red blood cells as raw materials. In clinical practice, the doctor will prescribe ferrous succinate with or without vitamin C according to their own preferences. Vitamin C Involves in many biological processes in vivo, such as, collagen formation, tissue repair, the synthesis of phenylalanine, tyrosine, metabolism of folic acid, iron and maintains vascular integrity. Researchers have shown that increased iron intake with vitamin C can prevent anemia,the application of vitamin C can reduce the toxicity symptoms in genotoxic caused by ferric iron, it demonstrates that vitamin C is safe when combined with ferrous succinate. In theory, only the divalent iron can be absorbed in the duodenum and upper jejunum, vitamin C can oxidize ferric iron into divalent iron and maintains a certain degree of acidity in the intestine, and then promotes the absorption of iron. However, the feasibility in theory can not represent the clinical practice. So it's necessary to explore the efficacy and safety of vitamin C for iron supplementation in adult IDA patients through randomized controlled trial(RCT).

PROCEDURE Before the start of this study, the manila envelope is used to carry out the random allocation scheme, different treatment options are randomly loaded into the envelope according to the randomization generated by Stata 11.0 software. In terms of the inclusion criteria, We write the serial number of patients on the envelope after signing informed consent form and give different treatments according to the internal treatment option in envelope. In addition to the above treatment, increased intake of protein, calcium, iron, vitamins and essential fatty acids, appropriate heat are also advised at the same time. In order to check the compliance of the subject, the drug package and aluminum cardboard are asked to return to researchers at follow-up every two weeks, patients should be emphasized that they return all the drug packages, including the pharmaceutical packages that are not taken and run out of, which will help researchers to analyze the patient medication correctly. The number of tablets is to count and determine how much of the remaining drugs and the drugs the patients have taken. During the period of study, patients who participate in this study are not allowed to use other drugs that may affect the effect of iron supplementation. In special circumstances, the patient will be excluded because of using other drugs that affect the absorption of iron or vitamin C. The patients will receive blood routine examination at follow-up every two weeks, the results of examination,the reason and number of termination and loss, the incidence of adverse events in patients, such as, nausea, vomiting, abdominal pain, diarrhea and constipation are all recorded. Finally, we analyze the data to determine the effect and safety of vitamin C for iron supplementation. In this study, we hypothesis that vitamin C can increase the absorption of iron and accelerates the recovery of anemia, it also increases the incidence of gastrointestinal adverse events because of increased iron absorption at the same time.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia, Iron-Deficiency
Intervention  ICMJE
  • Drug: ferrous succinate and vitamin C
    As experimental group, when patients take the tablets of ferrous succinate, they also take vitamin C at the same time
  • Drug: ferrous succinate
    As active comparator, patients take the tablets of ferrous succinate with normal dosage in clinical practice
  • Drug: ferrous succinate
    As another active comparator, patients take the tablets of ferrous succinate with double dosage
Study Arms  ICMJE
  • Experimental: ferrous succinate and vitamin C
    In this group, the patients received 100mg ferrous succinate and 200mg vitamin C three times per day for 3-4 months
    Intervention: Drug: ferrous succinate and vitamin C
  • Active Comparator: ferrous succinate with normal dosage
    In this group, the patients received 100mg ferrous succinate three times per day for 3-4 months
    Intervention: Drug: ferrous succinate
  • Active Comparator: ferrous succinate with double dosage
    In this group, the patients received 200mg ferrous succinate three times per day for 3-4 months
    Intervention: Drug: ferrous succinate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2019)
440
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2015)
600
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hemoglobin (Hb) < 120 g/L in men and Hb < 110 g/L in women; Mean Corpuscular Volume(MCV) < 80 fl, Mean Corpuscular Hemoglobin(MCH) < 27 pg, and Mean Corpuscular Hemoglobin Concentration(MCHC) < 0.32; the blood biochemical examination: serum ferritin < 12 g/L, serum iron < 8.95 mol/L, transferrin saturation <15%, and total iron binding capacity>64.44 mol/L; with a history of Menorrhagia, monophagia or eating disorders; Willing to sign a Informed consent form.

Exclusion Criteria:

  • Pregnant women; drug allergy; the patients with serious gastrorrhagia, other peptic ulcers, active bleeding, hepatic insufficiency, heart disease or renal insufficiency; those patients can't tolerate the medicine orally, or participate in other clinical study, or refuse to sign a Informed consent Form.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02631668
Other Study ID Numbers  ICMJE KY2015-270
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party xiao-qin wang, Huashan Hospital
Study Sponsor  ICMJE Huashan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qin X Wang, doctorate Huashan Hospital
PRS Account Huashan Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP