MedDataX Logo

Effect of Calcium Plus Vitamin D Supplementation on Adolescent Mother and Infant Bone Health

NCT ID: NCT01732328

Last Updated: 2012-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lactation Bone Loss Infant Bone Growth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

Inactive pill (microcrystalline cellulose and corn starch) taken daily

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Calcium plus vitamin D

600mg of calcium and 200 international units (IU) vitamin D taken daily

Group Type ACTIVE_COMPARATOR

Calcium plus vitamin D

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Calcium plus vitamin D

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 13-19 y old
* between 23 and 29 wk of gestation
* primiparous
* carrying single fetus
* intending to exclusively or predominantly breastfeed

Exclusion Criteria

* chronic health problems
* smokers
* users of nutritional supplements, except iron supplements provided during standard prenatal care
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rio de Janeiro State University

OTHER

Sponsor Role collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Flavia Fioruci Bezerra

DSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Flavia F Bezerra, DSc

Role: PRINCIPAL_INVESTIGATOR

Universidade do Estado do Rio de Janeiro, Brazil

Carmen M Donangelo, PhD

Role: STUDY_DIRECTOR

Universidade Federal do Rio de Janeiro, Brazil

References

Explore related publications, articles, or registry entries linked to this study.

Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

Reference Type DERIVED
PMID: 39077939 (View on PubMed)

Rached V, Diogenes MEL, Donangelo CM, Bezerra FF. Calcium plus vitamin D supplementation during pregnancy reduces postpartum fat mass in adolescents: A randomized trial. Am J Hum Biol. 2023 Sep;35(9):e23911. doi: 10.1002/ajhb.23911. Epub 2023 May 11.

Reference Type DERIVED
PMID: 37166151 (View on PubMed)

Diogenes ME, Bezerra FF, Rezende EP, Donangelo CM. Calcium Plus Vitamin D Supplementation During the Third Trimester of Pregnancy in Adolescents Accustomed to Low Calcium Diets Does Not Affect Infant Bone Mass at Early Lactation in a Randomized Controlled Trial. J Nutr. 2015 Jul;145(7):1515-23. doi: 10.3945/jn.114.208140. Epub 2015 May 27.

Reference Type DERIVED
PMID: 26019245 (View on PubMed)

Diogenes ME, Bezerra FF, Rezende EP, Taveira MF, Pinhal I, Donangelo CM. Effect of calcium plus vitamin D supplementation during pregnancy in Brazilian adolescent mothers: a randomized, placebo-controlled trial. Am J Clin Nutr. 2013 Jul;98(1):82-91. doi: 10.3945/ajcn.112.056275. Epub 2013 May 29.

Reference Type DERIVED
PMID: 23719547 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CNPq

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CAAE 0002.0361.000-09

Identifier Type: -

Identifier Source: org_study_id