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

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 |

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
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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
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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
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Drug: ferrous succinate
As another active comparator, patients take the tablets of ferrous succinate with double dosage |
- Hemoglobin [ Time Frame: two weeks ]The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the second week
- 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.

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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 |
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.

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
China, Shanghai | |
Hushan Hospital | |
Shanghai, Shanghai, China, 200040 |
Principal Investigator: | Qin X Wang, doctorate | Huashan Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
iron deficiency anemia, vitamin C, ferrous succinate |
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 |