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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

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.

Condition or disease Intervention/treatment Phase
Anemia, Iron-Deficiency Drug: ferrous succinate and vitamin C Drug: ferrous succinate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Vitamin C for Iron Supplementation Therapy in Adult Patients With Iron Deficiency Anemia(IDA)
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron Vitamin C

Arm Intervention/treatment
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
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

Active Comparator: ferrous succinate with normal dosage
In this group, the patients received 100mg ferrous succinate three times per day for 3-4 months
Drug: ferrous succinate
As active comparator, patients take the tablets of ferrous succinate with normal dosage in clinical practice

Active Comparator: ferrous succinate with double dosage
In this group, the patients received 200mg ferrous succinate three times per day for 3-4 months
Drug: ferrous succinate
As another active comparator, patients take the tablets of ferrous succinate with double dosage




Primary Outcome Measures :
  1. Hemoglobin [ Time Frame: two weeks ]
    The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the second week


Secondary Outcome Measures :
  1. Reticulocyte [ Time Frame: two weeks ]
    The increased levels of reticulocyte after receiving three different treatment regimens are evaluated in the second week

  2. Hemoglobin [ Time Frame: four weeks ]
    The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the fourth week

  3. Ferritin [ Time Frame: eight weeks ]
    The increased levels of ferritin after receiving three different treatment regimens are evaluated in the eighth week

  4. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631668


Locations
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China, Shanghai
Hushan Hospital
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Huashan Hospital
Investigators
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Principal Investigator: Qin X Wang, doctorate Huashan Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: xiao-qin wang, professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02631668    
Other Study ID Numbers: KY2015-270
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by xiao-qin wang, Huashan Hospital:
iron deficiency anemia, vitamin C, ferrous succinate
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ascorbic Acid
Ferrous succinate
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hematinics