the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients
Condition: Anemia, Iron-Deficiency
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): ferrous succinate and vitamin C; ferrous succinate; ferrous succinate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): As experimental group, when patients take the tablets of ferrous succinate, they also take vitamin C at the same time; As active comparator, patients take the tablets of ferrous succinate with normal dosage in clinical practice; As another active comparator, patients take the tablets of ferrous succinate with double dosage
Intervention MeSH terms: Ferrous succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: iron deficiency anemia, vitamin C, ferrous succinate