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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:

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
Sponsor: Huashan Hospital

Current Primary Outcome: Hemoglobin [ Time Frame: two weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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: Same as current

Information By: Huashan Hospital

Dates:
Date Received: December 14, 2015
Date Started: January 2016
Date Completion: December 2018
Last Updated: August 15, 2016
Last Verified: August 2016