Study Comparing Two Isoforms of Vitamin D Supplements for Infants

NCT01190137 | Completed Phase 3

• 1 other identifier: A09-M108-09A
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

There are two different types of vitamin D - vitamin D3 (animal source) and vitamin D2 (plant source). Almost all the usual vitamin D preparations for infants available in Canadian pharmacies contain vitamin D3 which may not be suitable for families who avoid animal products for social or religious reasons. The purpose of this study is to learn more about the two forms of vitamin D and if blood levels of vitamin D are similar in infants after taking them. Forty-eight breastfed infants will be randomly assigned to 400 IU of either vitamin D2 or D3 supplement for 3 months starting at 1 month of age. The difference in blood vitamin D levels, after 3 months of supplementation, between the two groups will help determine if the two supplements are equal.

Conditions

Healthy

Keywords

Optimal vitamin D status; 25-hydroxy vitamin D; Rickets and bone mineralization; Breast fed infants; Cholecalciferol and ergocalciferol

Outcome Measures

Primary Outcomes (1)

• Equivalency of isoforms

  To compare the relative ability of daily oral supplementation of 400 IU in the form of vitamin D3 or D2 to achieve and sustain optimal plasma 25(OH)D concentrations, defined as 25(OH)D values between 75-225 nmol/L, in exclusively breastfed infants.

  3 months

Study Arms (2)

400 IU Vitamin D3

ACTIVE COMPARATOR

Dietary Supplement: Cholecalciferol (D3) or ergocalciferol (D2)

400 IU Vitamin D2

EXPERIMENTAL

Dietary Supplement: Cholecalciferol (D3) or ergocalciferol (D2)

Interventions

Cholecalciferol (D3) or ergocalciferol (D2) DIETARY_SUPPLEMENT

400 IU administered as 1 drop daily for 3 months

Also known as: Baby D Drops

400 IU Vitamin D2; 400 IU Vitamin D3

Eligibility Criteria

• Age: 2 Weeks - 6 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy, singleton term infants of appropriate for gestational age, according to Centers for Disease Control (CDC) growth charts based on weight at birth between 5th and 95th percentiles for sex
• Born to healthy breastfeeding women
• Exclusively breast fed infants from birth, according to WHO definition: breast milk, expressed breast milk, vitamins, minerals and medicine but not including water, breast milk substitutes, other liquids and solid foods.

You may not qualify if:

• Infants of mothers with a history of gestational diabetes or hypertension in pregnancy; chronic alcohol use; malabsorption syndromes (Celiac disease, Crohn's, etc.), due to malabsorption of fat soluble vitamins
• Mothers taking any medications that can affect vitamin D metabolism (anticonvulsants and corticosteroids)
• Mothers taking ≥ 2,000 IU/d of vitamin D from supplementation

Sponsors & Collaborators

• McGill University: lead
• Canadian Foundation for Dietetic Research (CFDR): collaborator

Study Sites (1)

Mary Emily Clinical Nutrition Research Unit

Ste. Anne de Bellevue, Quebec, H9X 3V9, Canada

Location

Related Publications (2)

• Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

  PMID: 33305842 DERIVED

• Gallo S, Phan A, Vanstone CA, Rodd C, Weiler HA. The change in plasma 25-hydroxyvitamin D did not differ between breast-fed infants that received a daily supplement of ergocalciferol or cholecalciferol for 3 months. J Nutr. 2013 Feb;143(2):148-53. doi: 10.3945/jn.112.167858. Epub 2012 Dec 19.

  PMID: 23256143 DERIVED

MeSH Terms

Conditions

Rickets; Breast Feeding

Interventions

Cholecalciferol; Ergocalciferols

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Hope A, Weiler, PhD, RD

  McGill University

  PRINCIPAL INVESTIGATOR

• Celia Rodd, MD

  Montreal Children's Hospital, McGill University Health Center

  PRINCIPAL INVESTIGATOR

• Sina Gallo, MSc, RD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 27, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 2, 2012

Record last verified: 2012-03

Locations

CA (1)