Relative Bioavailability of Iron and Folic Acid in New Test Supplement

NCT00789490 | Completed Phase 1 DMC

• 1 other identifier: Sickkids REB 1000007811
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Deficiencies of iron and folic acid during pregnancy can lead to adverse outcomes for the fetus, thus supplements are recommended. Adherence to current tablet-based supplements is documented to be poor. Recently a powdered form of micronutrients has been developed which may decrease side-effects and thus improve adherence. However, before testing the efficacy of the supplement as an alternate choice for supplementation during pregnancy, the bioavailability of the iron needs to be determined. The objective of this study is to measure the relative bioavailability of iron and folic acid from a powdered supplement that can be sprinkled on semi-solid foods or beverages versus a traditional tablet supplement in pregnant women.

Conditions

Iron Deficiency; Folic Acid Deficiency

Keywords

pregnancy; relative bioavailability; iron; folic acid; ferric pyrophosphate; Study focus is to compare the relative bioavailability of SuppleFem Sprinkles to the current tradtional tablet Materna in pregnant women

Outcome Measures

Primary Outcomes (1)

• The primary outcome is a comparison of area under the curve (AUC) for change in serum iron for each intervention adjusted for diurnal variation. The use of AUC will provide a single outcome for each participant.

  3 weeks

Secondary Outcomes (1)

• The secondary outcome is a comparison of area under the curve (AUC) for change in serum folate for each intervention

  2 weeks

Interventions

Daminaide 995 - SuppleFem Sprinkles DIETARY_SUPPLEMENT

The study agent SuppleFem will be a preblend manufactured by Acatris in Oakville Ontario and will be repackaged into 1 gram aliquots in white plastic Tamper Seal Vials.1 ram to be taken with test meal

Materna DIETARY_SUPPLEMENT

Materna is a pregnancy supplement available on the Canadian market and is manufactured by Wyeth. Dose is 1 tablet per day

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women between 18 and 45 years of age in the second or third trimester of pregnancy (24-32 weeks of gestational age).
• Normal Hb (Hb≥110g/L and Hb≤144g/L)

You may not qualify if:

• Chronic illness (clinically significant neurological, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic diseases)
• A history or presence of hemosiderosis, hemochromatosis, peptic ulcer, regional enteritis, ulcerative colitis
• A history of or current use of IV iron therapy or erythropoietin therapy
• A history or presence of any clinically significant gastrointestinal pathology (eg. chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved gastrointestinal symptoms (eg. diarrhea or vomiting), steatorrhea, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of iron or folic acid
• Abnormal hemoglobin electrophoresis ie. sickle cell anemia, thalassemia, etc.
• Current acute illness and/or taking antibiotics
• Known or suspected allergies to Materna®, or any ingredient present in Materna or SuppleFem Sprinkles or any of the foods to be consumed during the trial.
• Mildly to severely anemic women (Hb\<110 g/L) or elevated hemoglobin (above 144g/L)
• Complications in pregnancy (including pregnancy induced hypertension, preeclampsia, a history of severe antepartum hemorrhage)
• Blood transfusion within last 3 months

Sponsors & Collaborators

• University of Toronto: lead
• The Hospital for Sick Children: collaborator
• Heinz Endowments: collaborator

Study Sites (1)

The Hospital For Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Hartman-Craven B, Christofides A, O'Connor DL, Zlotkin S. Relative bioavailability of iron and folic acid from a new powdered supplement compared to a traditional tablet in pregnant women. BMC Pregnancy Childbirth. 2009 Jul 27;9:33. doi: 10.1186/1471-2393-9-33.

  PMID: 19635145 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Folic Acid Deficiency

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 13, 2008
• Study Start: October 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: November 13, 2008

Record last verified: 2008-11

Locations

CA (1)