Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants

NCT00381914 | Completed Phase 2

• 1 other identifier: HW-06-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they have designed a study to determine how much dietary vitamin D is needed to optimize health in infants. This is important since many infants are born with vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is unclear and recent research suggests that vitamin D status very early in life has long lasting effects on bone mass and other health issues. Therefore, in a group of healthy infants, this research team will test which dosage of vitamin D is needed to achieve optimal vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D and bone status in blood and also general health. The infants will all be breastfed and begin the study at about 2 weeks of age. At 3 months intervals over the first year of life, each infant will be measured for growth, duration of breastfeeding and supplement use plus have a bone density scan to determine changes in bone growth. The data will be helpful to guide health care professionals in providing the best care possible for their infants. It will also be important to the health of populations since dietary recommendations for vitamin D are used to guide fortification of foods and development of evidence based policy around nutrient recommendations and their implementation.

Conditions

Vitamin D Deficiency

Keywords

Infants; Vitamin D; Dose-response

Outcome Measures

Primary Outcomes (1)

• Vitamin D plasma concentrations

  25(OH)D concentrations will me measured in infants over the first year of life. The blood sampling will be done at 1, 2, 3, 6, 9 and 12 months of age. Monitoring the vitamin D concentrations will allow the investigators to determine the best dose of vitamin D for breast fed infants receiving one of three vitamin D dosages.

  12 months

Secondary Outcomes (1)

• Bone mineral content

  12 months

Study Arms (3)

1

EXPERIMENTAL

400 IU / day vitamin D

Drug: Vitamin D

2

EXPERIMENTAL

800 IU / day vitamin D

Drug: Vitamin D

3

EXPERIMENTAL

1200 IU / day vitamin D

Drug: Vitamin D

Interventions

Vitamin D DRUG

400 IU vitamin D / day

1

Eligibility Criteria

• Age: 2 Weeks - 5 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy singleton term born infants of appropriate size for gestational age (AGA) according to the Centers for Disease Control growth charts based on weight at birth between the 5th and 95th percentiles for sex; and born to healthy breastfeeding women. This allows us to assess growth and bone mineral accretion without bias of intrauterine growth restriction.

You may not qualify if:

• Infants of mothers with history of gestational diabetes or hypertension in pregnancy; chronic alcohol use; malabsorption syndromes due to malabsorption of vitamin D (celiac disease, Crohn's etc.); and multiple births.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Mary Emily Clinical Nutrition Research Unit

Sainte-Anne-de-Bellevue, Quebec, H9X 2E3, Canada

Location

Related Publications (5)

• Gharibeh N, Gallo S, Sotunde OF, Vanstone CA, Rodd CJ, Weiler HA. Patterns of Bone Mineral Accretion and Sex Differences in Healthy Term Vitamin D Replete and Breastfed Infants From Montreal, Canada: Bone Mass Reference Data. J Clin Densitom. 2022 Jan-Mar;25(1):43-53. doi: 10.1016/j.jocd.2021.07.004. Epub 2021 Jul 24.

  PMID: 34479797 DERIVED

• 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

• Mok E, Vanstone CA, Gallo S, Li P, Constantin E, Weiler HA. Diet diversity, growth and adiposity in healthy breastfed infants fed homemade complementary foods. Int J Obes (Lond). 2017 May;41(5):776-782. doi: 10.1038/ijo.2017.37. Epub 2017 Feb 6.

  PMID: 28163319 DERIVED

• Hazell TJ, Gallo S, Berzina I, Vanstone CA, Rodd C, Weiler HA. Plasma 25-hydroxyvitamin D, more so than its epimer, has a linear relationship to leaner body composition across infancy in healthy term infants. Appl Physiol Nutr Metab. 2014 Oct;39(10):1137-43. doi: 10.1139/apnm-2013-0586. Epub 2014 May 1.

  PMID: 25004404 DERIVED

• Gallo S, Comeau K, Vanstone C, Agellon S, Sharma A, Jones G, L'Abbe M, Khamessan A, Rodd C, Weiler H. Effect of different dosages of oral vitamin D supplementation on vitamin D status in healthy, breastfed infants: a randomized trial. JAMA. 2013 May 1;309(17):1785-92. doi: 10.1001/jama.2013.3404.

  PMID: 23632722 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hope A Weiler, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

• Celia Rodd, MD

  Montreal Children's Hospital of the MUHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 28, 2006
• Study Start: March 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 2, 2012

Record last verified: 2012-03

Locations

CA (1)