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

NCT02631668 | Completed Phase 4

• 1 other identifier: KY2015-270
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Iron-Deficiency

Keywords

iron deficiency anemia, vitamin C, ferrous succinate

Outcome Measures

Primary Outcomes (1)

• Hemoglobin

  The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the second week

  two weeks

Secondary Outcomes (4)

• Reticulocyte

  two weeks

• Hemoglobin

  four weeks

• Ferritin

  eight weeks

• adverse events

  every two weeks

Study Arms (3)

ferrous succinate and vitamin C

EXPERIMENTAL

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

ferrous succinate with normal dosage

ACTIVE COMPARATOR

In this group, the patients received 100mg ferrous succinate three times per day for 3-4 months

Drug: ferrous succinate

ferrous succinate with double dosage

ACTIVE COMPARATOR

In this group, the patients received 200mg ferrous succinate three times per day for 3-4 months

Drug: ferrous succinate

Interventions

ferrous succinate and vitamin C DRUG

As experimental group, when patients take the tablets of ferrous succinate, they also take vitamin C at the same time

ferrous succinate and vitamin C

ferrous succinate DRUG

As active comparator, patients take the tablets of ferrous succinate with normal dosage in clinical practice

ferrous succinate with normal dosage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Hushan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (7)

• Brugnara C. A hematologic "gold standard" for iron-deficient states? Clin Chem. 2002 Jul;48(7):981-2. No abstract available.

  PMID: 12089163 BACKGROUND

• McCarley P. The KDOQI clinical practice guidelines and clinical practice recommendations for treating anemia in patients with chronic kidney disease: implications for nurses. Nephrol Nurs J. 2006 Jul-Aug;33(4):423-6, 445; quiz 427-8.

  PMID: 17002000 BACKGROUND

• Okam MM, Koch TA, Tran MH. Iron deficiency anemia treatment response to oral iron therapy: a pooled analysis of five randomized controlled trials. Haematologica. 2016 Jan;101(1):e6-7. doi: 10.3324/haematol.2015.129114. Epub 2015 Oct 30. No abstract available.

  PMID: 26518747 BACKGROUND

• Joseph B, Ramesh N. Weekly dose of Iron-Folate Supplementation with Vitamin-C in the workplace can prevent anaemia in women employees. Pak J Med Sci. 2013 Jan;29(1):47-52. doi: 10.12669/pjms.291.3016.

  PMID: 24353506 BACKGROUND

• Parveen N, Ahmad S, Shadab GG. Iron induced genotoxicity: attenuation by vitamin C and its optimization. Interdiscip Toxicol. 2014 Sep;7(3):154-8. doi: 10.2478/intox-2014-0021. Epub 2014 Dec 30.

  PMID: 26109893 BACKGROUND

• Rocha Dda S, Capanema FD, Netto MP, de Almeida CA, Franceschini Sdo C, Lamounier JA. Effectiveness of fortification of drinking water with iron and vitamin C in the reduction of anemia and improvement of nutritional status in children attending day-care centers in Belo Horizonte, Brazil. Food Nutr Bull. 2011 Dec;32(4):340-6. doi: 10.1177/156482651103200405.

  PMID: 22590967 BACKGROUND

• Li N, Zhao G, Wu W, Zhang M, Liu W, Chen Q, Wang X. The Efficacy and Safety of Vitamin C for Iron Supplementation in Adult Patients With Iron Deficiency Anemia: A Randomized Clinical Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2023644. doi: 10.1001/jamanetworkopen.2020.23644.

  PMID: 33136134 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous succinate; Ascorbic Acid

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Qin X Wang, doctorate

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: January 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)